[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Jiangsu Hansoh Pharmaceutical Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":598},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,42,0,25,[9,47,74,94,118,138,162,186,212,238,261,287,311,331,356,377,393,414,437,458,477,498,530,550,577],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":4},"100645001","phase-3-a-study-to-evaluate-the-safety-of-hs-10506-in-chinese-patients-with-insomnia-disorder-100645001",false,"NCT07677384","A Study to Evaluate the Safety of HS-10506 in Chinese Patients With Insomnia Disorder","A Multicenter, Open-label, Phase 3 Study to Evaluate the Short-term and Long-term Safety of HS-10506 in Chinese Adult Patients With Insomnia Disorder","Inclusion Criteria:\n\n1. Participants must be 18 to 65 years of age (inclusive 18, not inclusive 65);\n2. Participants are required to voluntarily sign the informed consent form;\n3. Body mass index (BMI): BMI (weight\u002Fheight2 \\[kg\u002Fm2\\]) must be in the range of 18 to 35 kg\u002Fm2 (inclusive);\n4. For Participants completed Study 301: Participants have completed the Study 301, can potentially benefit from extended treatment with HS-10506 and have no major safety risks according to the investigator's clinical judgment;\n5. For new Participants: Participants must meet Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-5) criteria for insomnia disorder;\n6. For new Participants: Participants must have Insomnia Severity Index (ISI) scores≥15 at screening;\n7. For new Participants: Participants must have an sSOL≥30 minutes, sWASO≥30 minutes, and sTST\\\u003C6.5 hours for at least three nights every week within one month prior to screening; and sSOL≥30 minutes, sWASO≥30 minutes, and sTST\\\u003C6.5 hours for at least 3 nights from sleep diary in the last 7 consecutive days before the first dose in the open-label treatment period;\n\nExclusion Criteria:\n\n1. Has received systemic hypnotherapy, cognitive behavioral therapy (CBT), or other non-pharmacological treatments for insomnia in last 4 weeks or have plans during the study;\n2. Has a risk of suicide according to the Columbia Suicide Severity Rating Scale (C-SSRS), or has a high risk of suicide at the discretion of the investigator;\n3. Has used any medication that may affect the pharmacokinetics of HS-10506 or GLP-1R-related single\u002Fmulti-target drugs within the past 2 weeks or 5 half-lives of the medication;\n4. Has used any medication that may affect sleep-wake function, or any other prohibited central nervous system active medications within 1 week or 5 half-lives of the medication;\n5. Has a history of drug dependency or abuse within the past 1 year or showed positive in urine drug test at screening;\n6. Has a history of alcohol abuse within the past 1 year or can't obey the rules of alcohol restriction;\n7. Has a history of smoking≥10 cigars daily within the past 3 months or can't obey the rules of cigar restriction;\n8. Has a history of caffeine consumption≥600 mg per day or can't obey the rules of caffeine restriction;\n9. Has been working across 3 or more time zones or shift work within 2 weeks prior to screening;\n10. Has taken more than 3 naps per week for\\>1 hour each time within the past 2 weeks prior to screening;\n11. Has any circumstances or conditions, which, in the opinion of the investigator, may affect the subject's full participation in the study or compliance with the protocol.\n12. For Participants completed Study 301: Has been diagnosed with a sleep-wake disorders or sleep-related breathing disorders other than insomnia disorder during Study 301, such as restless legs syndrome, periodic limb movement disorder, circadian rhythm disorder, narcolepsy, rapid eye movement sleep phase (REM) behavioral disorders, and obstructive sleep apnea;\n13. For Participants completed Study 301: Has been diagnosed with neurodevelopmental retardation, cognitive impairment, epilepsy, schizophrenia, bipolar disorder, hyperthyroidism, cancer, severe cardio-cerebrovascular diseases or respiratory diseases; or current chronic pain that affects sleep, nocturia resulting in frequent need to get out of bed to use the bathroom during the night; or clinically significant and\u002For unstable neurological, psychiatric, respiratory, cardiovascular, digestive, immunologic, urologic, endocrine diseases during Study 301; or other systemic diseases that are inappropriate for the study;\n14. For Participants completed Study 301: Previously participated in any clinical trial other than HS-10506-301 within 3 months prior to screening;\n15. For new Participants: Has history of\u002Fcurrent sleep-wake disorders or sleep-related breathing disorders other than insomnia disorder, such as restless legs syndrome, periodic limb movement disorder, circadian rhythm disorder, narcolepsy, rapid eye movement sleep phase (REM) behavioral disorders, and obstructive sleep apnea;\n16. For new Participants: Has history of\u002Fcurrent neurodevelopmental retardation, cognitive impairment, epilepsy, schizophrenia, bipolar disorder, hyperthyroidism, cancer, severe cardio-cerebrovascular diseases or respiratory diseases; or current chronic pain that affects sleep, nocturia resulting in frequent need to get out of bed to use the bathroom during the night; or clinically significant and\u002For unstable neurological, psychiatric, respiratory, cardiovascular, digestive, immunologic, urologic, endocrine diseases within the past 3 months prior to screening; or other systemic diseases that are inappropriate for the study;\n17. For new Participants: Previously use of HS-10506;\n18. For new Participants: Previously participated in any clinical trial within 3 months prior to screening.","ALL","18 Years","64 Years",{"count":21,"type":22},600,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","The primary purpose of this open-label phase Ⅲ study is to evaluate the safety of HS-10506 on the incidence and severity of adverse events (AE), serious adverse events (SAE), adverse events of special interest (AESI) in Chinese adult participants with insomnia disorder.",[28],"Insomnia Disorder",[30,31,32,33,34],"Clinical trial","insomnia disorder","open-label","long-term","phase 3","NOT_YET_RECRUITING","2026-06-24",{"date":38,"type":39},"2026-06-30","ACTUAL",{"date":41,"type":22},"2026-06-12",{"date":43,"type":22},"2029-06-30",{"name":45,"class":46},"Jiangsu Hansoh Pharmaceutical Co., Ltd.","INDUSTRY",{"id":48,"slug":49,"hasResults":12,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":54,"sex":17,"minAge":18,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":23,"phases":58,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":73},"100630112","phase-1-a-study-of-hs-20136-2-in-healthy-participants-100630112","NCT07483437","A Study of HS-20136-2 in Healthy Participants","A Randomized, Double-Blind, Placebo-Controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Subcutaneous Administration of HS-20136-2 Injection in Healthy Participants","Inclusion Criteria:\n\n1. Participants who are able to sufficiently understand the study content, process, and potential adverse reactions, and voluntarily sign the informed consent form;\n2. Healthy men and women aged 18-65 years (inclusive);\n3. Body weight ≥ 50 kg (male) or ≥ 45 kg (female) and body mass index (BMI) within the range of 25-35 (inclusive) \\[BMI = body weight\u002Fbody height2 (kg\u002Fm2)\\];\n\nExclusion Criteria:\n\n1. Pregnant or lactating women;\n2. Participants with a history of cardiovascular, respiratory, hepatic, renal, digestive tract, mental, neurological, hematological, immune, and metabolic abnormalities (such as unexplained recurrent hypoglycemia) and other diseases, and not suitable for the study as assessed by the investigator, such as: Childhood asthma (resolved),Depression (non-hospitalised, but potentially medicated in the past), Migraine, etc.\n3. Glycosylated hemoglobin A1c (HbA1c) \\> 6.5% or fasting blood glucose ≤ 3.9 mmol\u002FL (70 mg\u002FdL) or ≥ 6.1 mmol\u002FL (110 mg\u002FdL) during the screening period;\n4. The alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), and total bilirubin (TBIL) \\> 1.5 × ULN during the screening period (except for cases of known Gilbert's Syndrome);\n5. Participating in any clinical study involving drugs or medical devices (except for those not receiving an investigational drug or investigational device) within 3 months before screening or 5 half-lives (whichever is longer) before screening, or currently participating in a clinical trial;\n6. Treatment with systemic steroids, immunomodulators, or chemotherapy within 3 months before screening or likely to receive them during the study;\n7. Known severe allergic disease, or known allergies to GLP-1R agonists or Retatrutide, or allergic constitution (allergies to various drugs and foods);\n8. With concomitant diseases that may significantly affect the absorption of drugs or nutrients as judged by the investigator, such as clinically significant gastrointestinal diseases (e.g., active inflammatory bowel disease) and symptoms of gastrointestinal disorders; or any condition that might affect the absorption of drugs, such as subtotal or total gastrectomy, sleeve gastrectomy, gastric bypass surgery, and resection of any intestinal area;\n9. History of confirmed chronic pancreatitis or idiopathic acute pancreatitis, or serum amylase or lipase greater than the upper limit of normal at screening. A participant with a history of acute pancreatitis caused by gallstones may be included in the study if the participant has a cholecystectomy to resolve the problem;\n10. Have a history of symptomatic gallbladder disease within the past 2 years, defined by the presence of gallstones on an imaging study and abdominal pain attributed to the gallstones by the participant's physician; subjects who had a procedure to remove the gallstones and\u002For the gallbladder (cholecystectomy), with no long-term complications, are eligible for participation as long as the procedure was completed at least 3 months prior to screening;\n11. Diet or weight loss treatment within 3 months prior to administration (regardless of the reason) or having body weight change of more than 5% or a significant change in living habits within 3 months prior to administration;\n12. Other reasons for exclusion, as determined by the investigator.",true,"65 Years",{"count":57,"type":22},38,[59],"PHASE1","This is a randomized, double-blind,placebo-controlled phase I clinical study.The main purpose is to assess the safety and tolerability of single subcutaneous administration of HS-20136-2 injection in healthy participants.",[62],"Healthy",[64],"HS-20136-2，single ascending dose，safety，tolerability","2026-05-28",{"date":67,"type":39},"2026-06-01",{"date":69,"type":22},"2026-05-15",{"date":71,"type":22},"2026-12-31",{"name":45,"class":46},1,{"id":75,"slug":76,"hasResults":12,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":23,"phases":83,"briefSummary":84,"conditions":85,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":91,"leadSponsor":93,"locationsCount":4},"100637573","phase-1-phase-1-study-of-hs-10541-as-monotherapy-or-in-combination-with-other-anti-cancer-therapies-in-patients-with-kras-g12c-mutation-advanced-solid-tumors-100637573","NCT07615413","Phase 1 Study of HS-10541 as Monotherapy or in Combination With Other Anti-cancer Therapies in Patients With KRAS G12C Mutation Advanced Solid Tumors.","A Phase I Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of HS-10541 as Monotherapy or in Combination With Other Anti-cancer Therapies in Participants With KRAS G12C Mutation Advanced Solid Tumors.","Inclusion Criteria:\n\n1. Voluntary participation and written informed consent..\n2. Aged 18 years or older (≥18 years), of any gender.\n3. Histologically or cytologically confirmed advanced solid tumor.\n4. At least one measurable lesion according to RECIST v1.1.\n5. ECOG PS of 0 to 1, with no deterioration within 2 weeks prior to the first dose.\n6. With a life expectancy \\> 12 weeks.\n7. Adequate bone marrow reserve and organ function.\n8. Female participants of childbearing potential and non-sterilized male participants must agree to use highly effective contraceptive measures from the time of signing the ICF until 6 months after the last dose.\n9. Female participants of childbearing potential must be non-lactating; all female participants must have a negative pregnancy test prior to the first dose.\n\nExclusion Criteria:\n\n1. Uncontrolled pleural effusion, pericardial effusion, or abdominal effusion requiring clinical intervention.\n2. Presence of symptomatic brain metastases, leptomeningeal\u002Fbrainstem involvement, history of intracranial hemorrhage or intraspinal hemorrhage, or spinal cord compression.\n3. Unresolved CTCAE ≥grade 2 toxicities from previous anticancer therapy.\n4. History of a second primary malignancy\n5. Severe, uncontrolled, or active cardiovascular or cerebrovascular diseases, or severe cardiac examination abnormalities.\n6. Severe or poorly controlled diabetes mellitus or hypertension.\n7. Known active infectious diseases.\n8. Clinically significant gastrointestinal dysfunction.\n9. Gastrointestinal obstruction or perforation occured.\n10. Interstitial lung disease (ILD).\n11. Participants with known hypersensitivity or contraindications to any active or inactive ingredients of the study drug, chemically similar drugs, or drugs of the same class.\n12. Other inappropriate situation considered by the investigator.",{"count":82,"type":22},636,[59],"This is a multicenter, open-label phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of HS-10541 as monotherapy or in combination with other anti-cancer therapies in participants with KRAS G12C mutation advanced solid tumors.",[86],"KRAS G12C Mutation Advanced Solid Tumor","2026-05-22",{"date":89,"type":39},"2026-05-29",{"date":38,"type":22},{"date":92,"type":22},"2029-12-30",{"name":45,"class":46},{"id":95,"slug":96,"hasResults":12,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":54,"sex":17,"minAge":18,"maxAge":101,"enrollmentInfo":102,"targetDuration":4,"studyType":23,"phases":104,"briefSummary":105,"conditions":106,"keywords":109,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":115,"leadSponsor":117,"locationsCount":4},"100640012","phase-1-a-phase-i-single-and-multiple-dose-study-to-evaluate-the-safety-pharmacokinetics-and-pharmacodynamics-of-hs-10522-in-healthy-chinese-participants-and-chinese-participants-with-mild-hypertension-100640012","NCT07609875","A Phase I Single and Multiple Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of HS-10522 in Healthy Chinese Participants and Chinese Participants With Mild Hypertension","A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Oral Doses of HS-10522 Tablets in Healthy Chinese Participants and Chinese Participants With Mild Hypertension","Inclusion Criteria:\n\n\\-\n\nFor all participants:\n\n1. Able to understand the procedures and methods of the study, willing to strictly adhere to the clinical trial protocol to complete the study, and voluntarily sign the Informed Consent Form (ICF).\n2. Male or female participants aged 18 to 55 years (inclusive) at the time of signing ICF.\n3. At screening, body weight ≥ 50 kg for males and ≥ 45 kg for females, with a body mass index (BMI) between 19.0 and 28.0 kg\u002Fm² (inclusive).\n\nExclusion Criteria:\n\n1. Abnormal vital signs, physical examination findings, or laboratory test results at screening that are deemed clinically significant by the investigator.\n2. Presence of orthostatic hypotension or orthostatic tachycardia at screening.\n3. Clinically significant abnormal findings on the 12-lead ECG at screening, as judged by the investigator.\n4. Use of any medication within 2 weeks or 5 half-lives (whichever is longer) prior to screening, or anticipation of needing such medication during the trial.\n5. Known secondary causes of hypertension, or diseases that may affect adrenal function (e.g., renal artery stenosis, poorly controlled or untreated hyperthyroidism, poorly controlled or untreated hypothyroidism, hyperparathyroidism, pheochromocytoma, Cushing's syndrome).\n6. Participation in any other clinical trial of a drug or medical device within 12 weeks prior to screening, with receipt of at least one dose (including placebo), or currently within 5 half-lives of the last dose of the investigational product (whichever is longer).\n7. Participants who, in the opinion of the investigator, are likely to be non-compliant or are unsuitable for participation in this trial for any other reason.","55 Years",{"count":103,"type":22},88,[59],"The purpose of this study is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of ascending single and multiple oral doses of HS-10522 in healthy Chinese participants and Chinese participants with mild hypertension.",[107,108],"Healthy Adult","Hypertension",[110],"hypertension","2026-05-19",{"date":113,"type":39},"2026-05-27",{"date":67,"type":22},{"date":116,"type":22},"2027-02-03",{"name":45,"class":46},{"id":119,"slug":120,"hasResults":12,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":4,"eligibilityCriteria":124,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":125,"targetDuration":4,"studyType":23,"phases":127,"briefSummary":128,"conditions":129,"keywords":130,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":135,"leadSponsor":137,"locationsCount":4},"100640374","phase-3-a-study-of-hs-10506-in-chinese-patients-with-insomnia-disorder-100640374","NCT07587385","A Study of HS-10506 in Chinese Patients With Insomnia Disorder","A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of HS-10506 in Chinese Adult Patients With Insomnia Disorder","Inclusion Criteria:\n\n1. participants must be 18 to 65 years of age (inclusive 18, not inclusive 65);\n2. participants are required to voluntarily sign the informed consent form;\n3. Body mass index (BMI): BMI (weight\u002Fheight2 \\[kg\u002Fm2\\]) must be in the range of 18 to 35 kg\u002Fm2 (inclusive);\n4. Participants must meet Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-5) criteria for insomnia disorder;\n5. Participants must have Insomnia Severity Index (ISI) scores ≥ 15 at screening and run-in period;\n6. Subjective sleep assessment: Participants must have an sSOL≥30 minutes, sWASO≥30 minutes, and sTST \\\u003C 6.5 hours for at least three nights every week within one month prior to screening; and sSOL ≥ 30 minutes, sWASO≥30 minutes, and sTST \\\u003C 6.5 hours for at least 3 nights from sleep diary in the last 7 consecutive days before V2 visit and V3 visit respectively;\n7. PSG: Participants must demonstrate a 2-night mean LPS ≥ 30 minutes with neither night \\\u003C 20 minutes, a 2-night mean WASO ≥ 30 minutes with neither nigh \\\u003C 20 minutes, and a 2-night mean TST \\\u003C 7 hours.\n\nExclusion Criteria:\n\n1. Has history of\u002Fcurrent sleep-wake disorders or sleep-related breathing disorders other than insomnia disorder, such as restless legs syndrome, periodic limb movement disorder, circadian rhythm disorder, narcolepsy, rapid eye movement sleep phase (REM) behavioral disorders, and obstructive sleep apnea;\n2. Has a Apnea-Hypopnea Index (AHI) ≥ 10 times\u002Fhour or periodic leg movement with arousal index (PLMAI) ≥ 10 times\u002Fhour monitored by PSG at V2 visit;\n3. Has history of\u002Fcurrent neurodevelopmental retardation, cognitive impairment, epilepsy, schizophrenia, bipolar disorder, hyperthyroidism, cancer, severe cardio-cerebrovascular diseases or respiratory diseases; or current chronic pain that affects sleep, nocturia resulting in frequent need to get out of bed to use the bathroom during the night; or clinically significant and\u002For unstable neurological, psychiatric, respiratory, cardiovascular, digestive, immunologic, urologic, endocrine diseases within the past 3 months prior to screening; or other systemic diseases that are inappropriate for the study;\n4. Has a Hamilton Anxiety Scale (HAM-A) score ≥ 14 or Hamilton Depression Scale (HAM-D-17) score ≥ 18;\n5. Has used any medication that may affect the pharmacokinetics of HS-10506 or GLP-1R-related single\u002Fmulti-target drugs within the past 2 weeks or 5 half-lives of the medication;\n6. Has used any medication that may affect sleep-wake function, or any other prohibited central nervous system active medications within 1 week or 5 half-lives of the medication;\n7. Has received systemic hypnotherapy, cognitive behavioral therapy (CBT), or other non-pharmacological treatments for insomnia in last 4 weeks or have plans during the study;\n8. Has been working across 3 or more time zones or shift work within 2 weeks prior to screening;\n9. Has taken more than 3 naps per week for \\> 1 hour each time within the past 2 weeks prior to screening;\n10. Has a risk of suicide according to the Columbia Suicide Severity Rating Scale (C-SSRS), or has a high risk of suicide at the discretion of the investigator;\n11. Has a history of drug dependency or abuse within the past 1 year or showed positive in urine drug test at screening;\n12. Has a history of alcohol abuse within the past 1 year or can't obey the rules of alcohol restriction;\n13. Has a history of smoking ≥ 10 cigars daily within the past 3 months or can't obey the rules of cigar restriction;\n14. Has a history of caffeine consumption ≥ 600 mg per day or can't obey the rules of caffeine restriction;\n15. Previously participated in any clinical trial of HS-10506;\n16. Has any circumstances or conditions, which, in the opinion of the investigator, may affect the participant's full participation in the study or compliance with the protocol.",{"count":126,"type":22},732,[25],"The primary purpose of this phase 3 study is to evaluate the safety and the efficacy of HS-10506 (change versus placebo) on latency to persistent sleep (LPS) and wakefulness after sleep onset (WASO) measured by polysomnography (PSG) in Chinese adult participants with insomnia disorder.",[28],[30,31,34],"2026-05-08",{"date":133,"type":39},"2026-05-14",{"date":89,"type":22},{"date":136,"type":22},"2028-08-12",{"name":45,"class":46},{"id":139,"slug":140,"hasResults":12,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":4,"eligibilityCriteria":144,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":145,"enrollmentInfo":146,"targetDuration":4,"studyType":23,"phases":148,"briefSummary":149,"conditions":150,"keywords":152,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":4},"100636605","phase-1-a-study-of-hs-10587-in-patients-with-advanced-solid-tumors-100636605","NCT07567859","A Study of HS-10587 in Patients With Advanced Solid Tumors","An Open-Label, Multi-Center Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic\u002FPharmacodynamic Characteristics, and Preliminary Efficacy of HS-10587 in Patients With Methylthioadenosine Phosphorylase (MTAP)-Deleted Advanced Solid Tumors","Inclusion Criteria:\n\n1. Participants who voluntarily participate in this clinical study, understand the study procedures, and are able to sign a written ICF.\n2. Participants with locally advanced or recurrent metastatic malignant solid tumors confirmed by histopathology or cytopathology who have failed or are intolerant to at least one line of prior standard treatment, or for whom no standard treatment exists.\n3. Evidence of MTAP deletion in the tumor tissue.\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n5. Life expectancy ≥12 weeks.\n6. At least one measurable lesion that would qualify as target lesion by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1).\n7. Female participants of childbearing potential are willing to take appropriate contraceptive measures and should not breastfeed; male participants are willing to use barrier contraception.\n\nExclusion Criteria:\n\n1. History of other primary malignancies.\n2. Presence of pleural\u002Fabdominal effusion or pericardial effusion requiring clinical intervention.\n3. Presence of leptomeningeal metastasis, spinal cord compression, or brainstem metastasis; known untreated brain metastases, or symptomatic\u002Funstable brain metastases.\n4. Participants who have any Grade ≥ 2 residual toxicity according to Common Terminology Criteria for Adverse Events (CTCAE, version 6.0) from prior anti-tumor therapies (except alopecia, pigmentation, and residual neurotoxicity).\n5. Inadequate bone marrow reserve or hepatic and renal functions.\n6. Severe, uncontrolled, or active cardiovascular diseases.\n7. Severe or poorly controlled diabetes.\n8. Severe or poorly controlled hypertension.\n9. Severe infection within 4 weeks prior to the first dose.\n10. Long-term corticosteroid therapy, history of other acquired\u002Fcongenital immunodeficiency disorders, or organ transplantation.\n11. Known active infectious diseases.\n12. Clinically significant gastrointestinal dysfunction.\n13. Moderate to severe pulmonary diseases that seriously affect respiratory function.\n14. Prior history of severe neurological or mental disorders.\n15. Female participants who are pregnant or breastfeeding, or plan to become pregnant during the study.\n16. History of severe allergies, or history of hypersensitivity reactions to any active or inactive ingredients of HS-10587 or to drugs with similar chemical structures to HS-10587 or drugs of the same class as HS-10587.\n17. Participants with any conditions that may jeopardize participant safety or interfere with study assessments, as judged by the investigator.","75 Years",{"count":147,"type":22},362,[59],"This is a Phase I, multicenter, open-label clinical trial with dose escalation\u002Fdose expansion phases, designed to evaluate the safety, tolerability, pharmacokinetic\u002Fpharmacodynamic (PK\u002FPD) profiles, and antitumor efficacy characteristics of HS-10587 in patients with MTAP-deleted advanced solid tumors.",[151],"MTAP Deletion",[153],"Advanced Solid Tumors","2026-04-28",{"date":156,"type":39},"2026-05-05",{"date":158,"type":22},"2026-06-04",{"date":160,"type":22},"2028-06-30",{"name":45,"class":46},{"id":163,"slug":164,"hasResults":12,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":4,"eligibilityCriteria":168,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":169,"enrollmentInfo":170,"targetDuration":4,"studyType":23,"phases":172,"briefSummary":174,"conditions":175,"keywords":177,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":73},"100635620","phase-2-a-study-of-the-effect-and-safety-of-hs-10390-in-the-treatment-of-participants-with-chronic-kidney-disease-100635620","NCT07555054","A Study of the Effect and Safety of HS-10390 in the Treatment of Participants With Chronic Kidney Disease","A Randomized, Multicenter, Double-blind, Parallel Active-control Study of the Efficacy and Safety of HS-10390 for the Treatment of Participants With Chronic Kidney Disease","Inclusion Criteria:\n\n1. Men and women aged 18-70 years old;\n2. Body mass index (BMI) ≥18.0 and \\\u003C50.0 kg\u002Fm\\^2 at screening;\n3. Currently on stable dose (maximum tolerated dose and at least one-half of the maximum labeled dose) of ACEI and\u002For ARB therapy for at least 4 weeks and treated for at least 3 months prior to the screening visit;\n4. Diagnosed with chronic kidney disease, and the estimated glomerular filtration rate (eGFR) was ≥30 and \\\u003C90 mL\u002Fmin\u002F1.73 m\\^2 calculated using the 2021 CKD-EPI creatine formula at screening;\n5. Urinary albumin\u002Fcreatinine ratio (UACR) was ≥300 and \\\u003C3000 mg\u002Fg for at least 2 times on different days detected by the local laboratory at screening;\n6. Systolic BP between 90 and 160 mmHg and diastolic BP between 60 and 100 mmHg;\n7. Agree to contraception.\n\nExclusion Criteria:\n\n1. A known or suspected allergy to the investigational medical drug or its components or excipients;\n2. Within 4 weeks before screening, the following drugs could not maintain the stable regimen: diabetes drugs, hypertension drugs, non-steroidal anti-inflammatory drugs;\n3. If glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are prescribed, the dose are unstable within 8 weeks before screening ;\n4. Participants with uncontrolled diabetes mellitus (HbA1c \\> 8%);\n5. Received any other study drug treatment within 30 days or 5 half-lives (whichever is longer) prior to screening;\n6. Polycystic kidney disease, lupus nephritis, anti-neutrophil cytoplasmic antibody (ANCA) -associated vasculitis, acute glomerulonephritis, bilateral renal artery stenosis;\n7. Acute kidney injury or dialysis treatment within 6 months before screening;\n8. Received kidney transplant, or plan to receive kidney transplant during the trial;\n9. Platelet\\\u003C 100×10\\^9\u002FL or hemoglobin value \\\u003C 90 g\u002FL or Hematocrit value \\\u003C 27% (0.27 V\u002FV) at screening;\n10. Elevations of transaminases (ALT and\u002For AST) \\>3 times upper limit of normal (ULN) or total bilirubin exceeding 1.5 times the upper limit of normal at screening;\n11. Serum potassium \\>5.5 mmol\u002FL at screening.","70 Years",{"count":171,"type":22},182,[173],"PHASE2","The purpose of the study was to evaluate the efficacy and safety of HS-10390 in participants with chronic kidney disease (CKD) with estimated glomerular filtration rate (eGFR) ≥ 30 and \\\u003C90 mL\u002Fmin\u002F1.73 m\\^2, and urinary albumin to creatinine ratio (UACR) ≥ 150 mg\u002Fg and \\\u003C 3000 mg\u002Fg",[176],"Chronic Kidney Disease",[178],"chronic kidney disease","2026-04-21",{"date":154,"type":39},{"date":182,"type":22},"2026-05-21",{"date":184,"type":22},"2028-12-31",{"name":45,"class":46},{"id":187,"slug":188,"hasResults":12,"nctId":189,"briefTitle":190,"officialTitle":190,"acronym":4,"eligibilityCriteria":191,"healthyVolunteers":54,"sex":17,"minAge":18,"maxAge":192,"enrollmentInfo":193,"targetDuration":4,"studyType":23,"phases":195,"briefSummary":196,"conditions":197,"keywords":199,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":73},"100634152","phase-1-a-phase-i-study-to-evaluate-the-effect-of-itraconazole-on-the-pharmacokinetics-of-hs-10506-in-healthy-chinese-adult-participants-100634152","NCT07535970","A Phase I Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of HS-10506 in Healthy Chinese Adult Participants","Inclusion Criteria:\n\n1. Sign the informed consent form before the trial, fully understand the trial content, procedures, and possible adverse events, and self-report the ability to complete the study in accordance with the trial regulations;\n2. Adult males and females (aged between 18 and 45 years, inclusive of boundary values, calculated on the date of signing the informed consent form);\n3. Participant's Body Mass Index (BMI) = weight (kg) \u002F height² (m²) within the range of 19.0-26.0 kg\u002Fm² (inclusive of boundary values); male participants weigh ≥ 50 kg, female participants weigh ≥ 45 kg;\n4. Agree to practice highly effective contraception from the signing of the informed consent form until 3 months after the last dose, and have no plans for pregnancy or sperm\u002Fegg donation during this period (only non-drug contraceptive measures are permitted during the trial).\n\nExclusion Criteria:\n\n1. Those with clinically significant abnormalities in physical examination, vital signs, oxygen saturation, 12-lead electrocardiogram, clinical laboratory tests, etc., deemed by the investigator as unsuitable for enrollment;\n2. Positive results for any one or more of hepatitis B surface antigen, hepatitis C antibody, human immunodeficiency virus antibody, or Treponema pallidum(TP)specific antibody during the screening period;\n3. 12-lead electrocardiogram results during the screening period showing QTcF\\>450.00 ms for males or QTcF\\>470.00 ms for females;\n4. Previous or current presence of severe diseases of the nervous system, psychiatric system, digestive system, circulatory system, respiratory system (e.g., anatomical abnormalities of the airway, congenital microstomia with macroglossia, mandibular hypoplasia; chronic obstructive pulmonary disease or sleep apnea syndrome), urinary system, endocrine and metabolic system, immune system, hematological system, etc., assessed by the investigator as unsuitable for participation in this study;\n5. Current or past history of psychiatric disorders or brain dysfunction, or assessment of suicide risk using the Columbia-Suicide Severity Rating Scale (C-SSRS), or self-injurious behavior or suicide attempt within one year before screening, or current suicide risk based on the investigator's clinical judgment;\n6. Current or past history of severe gastrointestinal diseases (e.g., Crohn's disease, ulcerative colitis, reflux esophagitis, etc.);\n7. Evidence of previous ventricular dysfunction, such as congestive heart failure (CHF)or a history of CHF;\n8. History of surgery within 3 months before screening, or planned surgery during the trial period, or surgery that may affect drug absorption, distribution, metabolism, or excretion, deemed by the investigator as unsuitable for enrollment;\n9. Participation in any other clinical trial involving any investigational drug or device within 3 months before screening, or within 7 half-lives of another investigational drug before screening, whichever is longer;\n10. Prone to allergic reactions, or allergic constitution(e.g., allergies to pollen, two or more drugs\u002Ffoods), or known allergy to components of HS-10506 tablets or itraconazole capsules;\n11. History of drug abuse, drug dependence, or use of illicit drugs within 5 years before screening, or positive drug abuse screening results;\n12. Frequent alcohol consumption within 3 months before screening (i.e., consuming more than 14 units of alcohol per week; 1 unit = 14 g alcohol, equivalent to 360 mL beer or 45 mL spirits with 40% alcohol content or 150 mL wine, equivalent to 10 bottles of beer, 500 mL spirits, or 3 bottles of wine per week), or inability to stop consuming alcoholic products during the trial, or positive alcohol breath test;\n13. Average daily smoking of more than 5 cigarettes within 3 months before screening, or inability to stop using any tobacco products during the trial;\n14. Excessive consumption of tea, coffee, and\u002For caffeinated beverages within 3 months before screening (average of more than 8 cups per day; 1 cup = 200 mL);\n15. Significant blood loss(≥200 mL)or blood donation within 3 months before screening, or plans for blood donation during the study or within 3 months after the study;\n16. Use of any drugs affecting CYP3A, CYP2C19 enzymes, or drugs altering gastric acid \\[proton pump inhibitors (PPIs), H2 receptor antagonists, topical antacids, oral alkaline drugs, etc.\\] within 30 days before the first dose of investigational product(or within 7 times the corresponding elimination half-life, whichever is longer);\n17. Use of any prescription drugs, over-the-counter drugs, herbal medicines, or health supplements(excluding topical preparations with local effects) within 14 days before the first dose of investigational product, or use of any drug within 7 half-lives (whichever is longer);\n18. Consumption of grapefruit or grapefruit products within 48 hours before the first dose of investigational product;\n19. Vaccination within 30 days before the first dose of investigational product, or planned use of vaccines during the study or within two weeks after the study;\n20. Significant changes in diet or sleep habits within 4 weeks before screening, assessed by the investigator as unsuitable for participation in this study;\n21. Female participants who are pregnant, breastfeeding, or have a positive pregnancy test result within 1 month before screening or during the trial period;\n22. Unprotected sexual intercourse within 14 days before screening;\n23. Special dietary requirements, inability to comply with a unified diet, or difficulty swallowing;\n24. Intolerance to venipuncture\u002Findwelling needle blood collection or fear of needles\u002Fblood;\n25. Inability to complete the study for other reasons or deemed unsuitable for participation by the investigator.","45 Years",{"count":194,"type":22},20,[59],"A single-center, open-label, fixed-sequence, self-controlled phase I clinical trial aimed at evaluating the effect of itraconazole capsules(CYP3A inhibitor) on the pharmacokinetics of HS-10506 tablets in healthy participants.",[198],"Healthy Participants",[200,201,202,203,198],"Phase 1","Drug interaction","Itraconazole","HS-10506","2026-04-10",{"date":206,"type":39},"2026-04-17",{"date":208,"type":22},"2026-04-30",{"date":210,"type":22},"2026-07-30",{"name":45,"class":46},{"id":213,"slug":214,"hasResults":12,"nctId":215,"briefTitle":216,"officialTitle":217,"acronym":4,"eligibilityCriteria":218,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":145,"enrollmentInfo":219,"targetDuration":4,"studyType":23,"phases":221,"briefSummary":222,"conditions":223,"keywords":225,"overallStatus":229,"whyStopped":4,"lastUpdateSubmitDate":230,"lastUpdatePostDateStruct":231,"startDateStruct":233,"completionDateStruct":235,"leadSponsor":237,"locationsCount":73},"100629139","phase-1-study-of-safety-and-efficacy-of-hs-10542-in-patients-with-paroxysmal-nocturnal-hemoglobinuria-100629139","NCT07470762","Study of Safety and Efficacy of HS-10542 in Patients With Paroxysmal Nocturnal Hemoglobinuria","A Phase IB\u002FII,Open Label Study to Assess Efficacy, and Safety, of HS-10542 in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) With Signs of Active Hemolysis","Inclusion Criteria:\n\n1. Men or women aged more than or equal to (≥) 18 years, and less than (≤) 75 years.\n2. It was confirmed to be PNH during screening, and the clone size of red blood cells or\u002Fand granulocytes or\u002Fand monocytes was detected by flow cytopy ≥10%\n3. Stable use of C5 complement inhibitor ikuzumab\u002Fcovalimab for the first 6 months of random treatment\n4. Have at least one blood transfusion record within the last 4 months, or sustain a hemoglobin level below 100g\u002FL the last 4 months prior to screening.\n5. The average hemoglobin level from two tests conducted by the laboratory at the time of screening is less than 100 g\u002FL, or hemoglobin level \\\u003C100g\u002FL before transfusion.\n6. LDH \\> 1.5 x Upper Limit of Normal (ULN) at the time of screening\n7. Inoccution of Neisseris meningitis and Streptococcus pneumoniae vaccine at least 2 weeks before the first administration of HS-10542;\n8. if HS-10542 treatment must begin less than 2 weeks after vaccination, preventive antibiotic treatment must begin at least 2 weeks after vaccination.\n9. Male and female subjects with fertility must agree to adopt efficient contraceptive measures with their partners within 60\u002F120 days from the signing of the informed consent form to the last administration,\n10. Male subjects who are infertile (such as those who have undergone effective sterilization surgery) must take additional efficient contraceptive measures when it is uncertain whether they have sperm，\n\nExclusion Criteria:\n\n1. Known or suspected hereditary or acquired complement deficiency\n2. Currently active primary or secondary immunodeficiency\n3. History of infection with pod bacteria (such as Neisseris meningitis, Streptococcus pneumoniae, etc.)\n4. Patients with laboratory evidence of bone marrow failure (reticulocytes \\\u003C100x109\u002FL; platelets \\\u003C30x109\u002FL; neutrophils \\\u003C0.5x109\u002FL);\n5. Presence of a bone marrow failure disorder (e.g., aplastic anemia, myelodysplastic syndrome, myelofibrosis)\n6. Presence of active anemia unrelated to PNH, such as renal anemia or anemia due to blood loss.\n7. There is or is suspected of systemic active bacteria, virus or fungal infection 2 weeks before the first administration of HS-10542 (according to the researcher's judgment)\n8. During screening, there are advanced heart disease (such as NYHA level IV),\n9. unstable thrombosis events that may exist for other causes,\n10. Abnormal ECG: The absolute value of QTcF (QT interval corrected by Fridericia 's formula \\> 450 msec for males and \\> 470 msec for females; or other clinically significant abnormalities as judged by the investigator.\n11. Major surgery within 3 months prior to the first dose. \\*Note: See Appendix for definitions of Grade 3\u002F4 surgeries.\n12. Known active infection requiring systemic therapy\n13. Diagnosed malignant tumors in the past 5 years\n14. Those who have a history of splenectomy or History of bone marrow\u002Fhematopoietic stem cells or solid organ transplantation\n15. Severe or poorly controlled hypertension\n16. poorly controlled diabetes\n17. Those who are suspected of being allergic to experimental drugs or any ingredient in experimental drugs\n18. Use any of the following drugs, unless there is a stable treatment plan before screening: a) erythropoietin (ESA), hypoxic-inducing factor proaminoyl hydroxylase inhibitor (HIF-PHI) or immunosuppressant for at least 8 weeks b) Systemic use of glucocorticoids (≤15 mg\u002Fday Prednisone or equivalent doses of glucocorticoids) at least 4 weeks c) Vitamin K antagonists (such as warfarin) have a stable international standardized ratio (INR) at least 4 weeks d) Low molecular weight heparin, oral anticoagulants such as aspirin, rvaroxaban, apifloxaban, etc. at least 4 weeks e) Iron supplements , vitamin B12, folic acid or androgen for at least 4 weeks\n19. Except for C5 complement inhibitors (including but not limited to ecucizumab and covalizumab), the situation of participating in other clinical trials or using other study drugs or approved therapies for experimental use before screening, and the trial drug is still within 5 half-lives or 2 weeks\n20. Participants who have previously received B-factor inhibitor treatment, with a treatment duration of no more than one week and having stopped taking the drug for more than five half-lives before screening, may not be excluded\n21. During screening, there are serious concurrent diseases, such as severe kidney disease (such as eGFR\\\u003C30 mL\u002Fmin\u002F1.73 m2, dialysis),\n22. ALT\u002FALP\\>3×ULN,\n23. Screening positive blood pregnancy test and breastfeeding women at the time of the visit,",{"count":220,"type":22},50,[59,173],"This was a phase 1b\u002F2,open label, multi-center study to assess efficacy and safety of HS-10542 in adulte patients with paroxysmal nocturnal hemoglobinuria (PNH) with signs of active hemolysis.",[224],"Paroxysmal Nocturnal Hemoglobinuria",[226,227,228],"HS-10542","paroxysmal nocturnal hemoglobinuria（PNH）","CFB","RECRUITING","2026-04-09",{"date":232,"type":39},"2026-04-13",{"date":234,"type":39},"2026-02-14",{"date":236,"type":22},"2029-07-31",{"name":45,"class":46},{"id":239,"slug":240,"hasResults":12,"nctId":241,"briefTitle":242,"officialTitle":243,"acronym":4,"eligibilityCriteria":244,"healthyVolunteers":54,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":245,"targetDuration":4,"studyType":23,"phases":247,"briefSummary":248,"conditions":249,"keywords":251,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":253,"lastUpdatePostDateStruct":254,"startDateStruct":256,"completionDateStruct":258,"leadSponsor":260,"locationsCount":73},"100631617","phase-1-phase-1-study-of-hs-20152-in-healthy-participants-100631617","NCT07503015","Phase 1 Study of HS-20152 in Healthy Participants","A Randomized, Double-blind, Placebo-Controlled, Single Ascending Dose, Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HS-20152 in Healthy Participants","Inclusion Criteria:\n\n1. Males or females aged 18 to 64 years (inclusive) when signing the ICF.\n2. Body Mass Index (BMI = weight\u002Fheight²) ≥ 19 kg\u002Fm² and ≤ 28 kg\u002Fm² at screening, and males must weigh ≥50 kg, and females must weigh ≥ 45 kg.\n3. Female participants must agree to practice highly effective contraception from 2 weeks prior to screening until 6 months after dosing.\n4. Male participants with childbearing potential must agree to practice highly effective contraception from the date of signing the ICF until 6 months after dosing; male participants without childbearing potential (e.g, having undergone effective sterilization) must agree to use additional highly effective contraception if there is any uncertainty about the presence of sperm.\n5. Participants should be able to complete vaccinations against Neisseria meningitidis (types A, C, Y, and W-135) and streptococcus pneumoniae at least 2 weeks prior to the first dose.\n6. The participants are able to communicate clearly with the investigator, understand and comply with the requirements of this study, have a comprehensive understanding of the study content, process and possible adverse reactions, and sign the ICF voluntarily.\n\nExclusion Criteria:\n\n1. Consumption of any caffeine, tea, alcohol, xanthine-rich foods or beverages within 24 hours before dosing.\n2. Consumption of red wine, citrus fruits (such as grapefruit, oranges, tangerines, etc.), grapes, mangoes, or star fruits, or juices containing these fruits, within 72 hours prior to dosing.\n3. Abnormal and clinically significant results in vital signs, physical examination, laboratory tests, 12-lead ECG, chest X-ray (anteroposterior and lateral)\u002FCT, or abdominal ultrasound at screening, which, in the investigator's judgement, may increase the participant's risk in the study or affect the interpretation of the study results.\n4. Positive for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), HCV Ab, HIV antibody, or syphilis-specific antibodies at screening.\n5. Presence of non-active, active, or latent tuberculosis infection at screening (indicated by chest X-ray or CT showing tuberculosis lesions, or positive T-SPOT.TB results).\n6. Positive pregnancy test at screening, or pregnant or breastfeeding at screening, or planning to become pregnant during the study.\n7. Use of any medications, including prescription drugs, over-the-counter (OTC) drugs, herbal medicines, or dietary supplements, within 2 weeks prior to screening, or within 5 half-lives after the last dose of such medications, whichever is longer.\n8. Receipt of any live attenuated vaccine within 30 days prior to dosing; receipt of any vaccine not specified in the protocol within 5 days prior to dosing; or planned receipt of any vaccine not specified in the protocol during the study.\n9. Participation in other drug or medical device intervention clinical trials within 1 month prior to screening, and receipt of investigational drugs or use of medical devices, or being within 5 half-lives of the last dose of other investigational drugs, whichever is longer; or adverse events (AEs) from other trials that have not resolved to CTCAE Grade 1 or normal at screening.\n10. Receipt of siRNA or antisense oligonucleotide therapy within 18 months prior to dosing.\n11. Blood donation or blood loss of ≥ 450 mL (excluding menstruation) within 3 months prior to screening, or planned blood donation during the study.\n12. Average smoking of \\> 5 cigarettes per day within 3 months prior to screening.\n13. Known history of drug abuse or drug use within 6 months prior to screening, or test positive for drug abuse at screening.\n14. Known history of alcohol dependence (average consumption of ≥14 units per week, with each unit equivalent to 285 mL of beer, 125 mL of wine, or 25 mL of spirits) within 6 months prior to screening, or positive alcohol breath test at screening.\n15. Undergone ≥ Grade 2 surgery within 6 months prior to screening, or plan to have surgery or hospitalization during the study.\n16. History of severe allergies to medications, foods, or environmental factors, or known allergies to the active substances or excipients of the investigational product (including HS-20152 and placebo).\n17. History of infection with encapsulated organisms (such as Neisseria meningitidis or Streptococcus pneumoniae), or close contact with individuals infected with Neisseria meningitidis.\n18. Difficulty with blood draws, inability to tolerate multiple venous blood draws, or any contraindications to blood draws; or severe skin conditions that, in the investigator's judgement, make subcutaneous injection unsuitable.\n19. Special dietary requirements or inability to comply with the dietary requirements of the study site.\n20. As judged by the investigator, any prior or current disease or condition that may increase the risk to the participant from participating in the study, interfere with the participant's compliance with the protocol, or affect the participant's ability to complete the study.",{"count":246,"type":22},32,[59],"This first-in-human, randomized, double-blind, placebo-controlled, single ascending dose study will evaluate the safety and tolerability of HS-20152, an investigational therapy targeting the complement pathway, in healthy adults. Secondary objectives include characterization of pharmacokinetics and pharmacodynamic effects on complement-related biomarkers.",[250],"Healthy Volunteers",[252],"HS-20152; Phase 1; Healthy volunteers","2026-03-25",{"date":255,"type":39},"2026-03-31",{"date":257,"type":22},"2026-04-22",{"date":259,"type":22},"2027-07-01",{"name":45,"class":46},{"id":262,"slug":263,"hasResults":12,"nctId":264,"briefTitle":265,"officialTitle":266,"acronym":226,"eligibilityCriteria":267,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":268,"enrollmentInfo":269,"targetDuration":4,"studyType":23,"phases":271,"briefSummary":272,"conditions":273,"keywords":277,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":279,"lastUpdatePostDateStruct":280,"startDateStruct":282,"completionDateStruct":284,"leadSponsor":286,"locationsCount":73},"100629435","phase-2-efficacy-and-safety-study-of-hs-10542-for-iga-nephropathy-100629435","NCT07474636","Efficacy and Safety Study of HS-10542 for IgA Nephropathy","A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Dose-Ranging Study to Evaluate the Efficacy and Safety of HS-10542 Capsules in Primary Immunoglobulin A (IgA) Nephropathy","Inclusion Criteria:\n\n1. Participant is a male or female≥18 years and≤74 years of age at the time of signing the informed consent.\n2. Body weight≥35kg, BMI\\\u003C37.5kg\u002Fm2.\n3. Primary IgA nephropathy was confirmed by renal biopsy within 8 years.\n4. 24-hour urine protein excretion≥1.0g\u002F24h, or UPCR≥0.8g\u002Fg at screening and prior to randomization.\n5. eGFR≥30 ml\u002Fmin\u002F1.73m2 at screening and prior to randomization；\n6. A fertile female participant or a male participant whose partner is a fertile female, who has not had a fertility, sperm\u002Fegg donation plan and voluntarily takes highly effective contraceptive measures (including the partner).\n7. All participants received RAS blocker treatment at least for 12 weeks, or demonstrated intolerance to RAS blockers, but has received SGLT2 inhibitors, endothelin receptor antagonists, or a mineralocorticoid receptor antagonist for at least 12 weeks, and have achieved the maximum recommended dose according to the product label or the maximum tolerated dose with stable dosing for at least 4 weeks prior to randomization.\n8. Participants should be able to complete vaccinations against Neisseria meningitidis (types A, C, Y, and W-135) and streptococcus pneumoniae at least 2 weeks prior to the first dose.\n9. Understand the research procedures and methods, voluntarily participate in this trial, and sign the informed consent form in person.\n\nExclusion Criteria:\n\n1. Participants with a history of severe allergies to drugs, food or the environment, or allergic to any RAS blockers, investigational products, or components as evaluated by the investigator;\n2. Participant has secondary forms of IgAN as defined by investigator (eg, IgA vasculitis nephritis, SLE) or participant has nephrotic syndrome (defined as proteinuria\\>3.5 g\u002Fday and serum albumin\\\u003C3.0 g\u002FdL, with or without edema);\n3. IgA nephropathy with rapid decline of renal function; Kidney pathology indicated that more than 50% of the glomerulus had large crescent body formation, which may affect the study results; Tubule atrophy - interstitial fibrosis of more than 50%;\n4. Patients with concomitant immunodeficiency disorders; or those with other systemic diseases assessed by the investigator as potentially causing proteinuria (e.g., diabetic nephropathy, autoimmune diseases, ANCA-associated vasculitis, etc.);\n5. Any organ transplant recipient, including those who have undergone solid organ transplants, bone marrow transplants and haematopoietic stem cell transplants.\n6. Participants with a medical history of invasive infections caused by capsulated bacteria, including Neisseria meningitidis and Streptococcus pneumoniae;\n7. Participants with chronic recurrent infections within 1 year prior to screening, such as liver abscess and pyelonephritis; Or participants with active infection who requiring intravenous antibiotic therapy within 2 weeks prior to randomization;\n8. Participants have a history of malignancy (except of radical excision of basal cell or squamous cell skin cancer, or cervical carcinoma in situ.), Participants with prior malignancy who have been documented to be cancer-free for≥5 years may be enrolled;\n9. Participants with a history of severe trauma or major surgery within 12 weeks prior to screening, or who plan to undergo surgery during the study period;\n10. Participants with a history of blood donation or a history of severe blood loss (≥400 mL blood loss) within 12 weeks prior to screening, or who have received blood transfusions within 12 weeks prior to screening;\n11. Participants had received systemic glucocorticoid therapy, immunosuppressive agents (e.g. mycophenolate mofetil or calcineurin inhibitors), Chinese patent medicines with immunosuppressive properties (e.g. Tripterygium wilfordii tablets), or renin inhibitors within 12 weeks of randomisation. Alternatively, they were assessed by the investigator as potentially requiring such treatments during the study period.\n12. Participants had received treatment with biologics (e.g. telitacicept, atacicept, povetacicept, sibeprenlimab, CD38 monoclonal antibodies), or with budesonide enteric capsules (NEFECON) or cytokine inhibitors, as well as other products related to the complement pathway (e.g. eculizumab, ravulizumab and avacopan), which were not included in the investigational drug of this study within 6 months prior to randomisation, or participants had received iptacopan within 12 weeks prior to randomization;\n13. Participants have a history of gastrointestinal surgery that may significantly affect the absorption, distribution, metabolism or excretion of drugs. Or have a history of severe gastrointestinal disease, or be experiencing symptoms of dysphagia or recurrent vomiting that cause difficulty eating or taking medication.\n14. Participants with poorly controlled severe systemic diseases at screening, including, but not limited to, severe hypertension (SBP≥180 mmHg and\u002For DBP110 mmHg), severe cardiac disease, pulmonary disease, hepatic disease or haematological disorders, which significantly increase the participant's safety risk as assessed by the investigator;\n15. Participants with a history of tuberculosis, or who have current symptoms, signs, imaging or laboratory evidence of active tuberculosis, or who have a positive IGRA tuberculosis infection screening test result (except the participants who have medical documented evidence of having received standardized preventive anti-tuberculosis treatment within the 5 years prior to screening);\n16. ALT or AST or total bilirubin levels\\>3×ULN at screening;\n17. Hb\\\u003C90 g\u002FL or PLT\\\u003C80×109\u002FL at screening;\n18. HBsAg positive; or HBsAg negative but HBcAb positive with HBV-DNA quantitative results exceeding the ULN defined by the local lab; HCV antibody positive with HCV-RNA quantitative results exceeding the ULN defined by the local lab; HIV antibody positive;\n19. HBA1C≥9.0% at screening;\n20. Participants who have participated in a clinical trial of any drug or medical device within 12 weeks prior to randomization and are expected to have residual effects of the investigational treatment (as determined by the investigator), or in any drug clinical trial within 30 days (or 5 half-lives of the investigational drug, whichever is longer) prior to screening, or who participated in a clinical trial of oligonucleotide drugs within 1 year prior to randomization;\n21. Women who are pregnant or breastfeeding prior to randomization;\n22. Drug or alcohol abuse within 6 months prior to randomization;\n23. Any illness or condition that the investigator deems likely to increase the risk of the trial, affect participants adherence to the protocol or prevent them from completing it.","74 Years",{"count":270,"type":22},90,[173],"This is a multicenter, randomized, double-blind, parallel, placebo-controlled study and is being conducted to evaluate the efficacy and safety of HS-10542 capsules for primary IgA nephropathy.",[274,275,276],"IgAN","Immunoglobulin A Nephropathy (IgAN)","Glomerular Disease",[274,278,226],"Immunoglobulin A Nephropathy","2026-03-11",{"date":281,"type":39},"2026-03-16",{"date":283,"type":22},"2026-03-17",{"date":285,"type":22},"2028-01-30",{"name":45,"class":46},{"id":288,"slug":289,"hasResults":12,"nctId":290,"briefTitle":291,"officialTitle":292,"acronym":4,"eligibilityCriteria":293,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":294,"targetDuration":4,"studyType":23,"phases":296,"briefSummary":297,"conditions":298,"keywords":300,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":302,"lastUpdatePostDateStruct":303,"startDateStruct":305,"completionDateStruct":307,"leadSponsor":309,"locationsCount":310},"100628992","phase-1-a-study-of-hs-10566-in-patients-with-high-risk-non-muscle-invasive-bladder-cancer-who-are-ineligible-for-or-refuse-radical-cystectomy-100628992","NCT07468851","A Study of HS-10566 in Patients With High-risk Non-muscle-invasive Bladder Cancer Who Are Ineligible for or Refuse Radical Cystectomy","A Phase I\u002FII Clinical Study Evaluating the Safety, Efficacy, Tolerability, and Pharmacokinetics of HS-10566 in Patients With High-risk Non-muscle-invasive Bladder Cancer Who Are Ineligible for or Refuse Radical Cystectomy","Inclusion Criteria:\n\n1. Men or women aged greater than or equal to (≥) 18 years.\n2. Signed informed consent form.\n3. Histologically confirmed non-muscle-invasive bladder urothelial carcinoma (i.e., transitional cell carcinoma). Mixed tumor types predominantly consisting of urothelial carcinoma are eligible. Patients diagnosed with neuroendocrine, micropapillary, signet-ring cell, plasmacytoid, or sarcomatoid features are excluded.\n4. Patients with non-muscle-invasive bladder cancer (NMIBC) who have undergone prior transurethral resection of bladder tumor (TURBT) and who refuse or are ineligible for radical cystectomy, and meet one of the following two populations:\n\n   1. Patients with high-risk non-muscle-invasive bladder cancer (HR-NMIBC) who are unresponsive to Bacillus Calmette-Guérin (BCG) therapy after prior TURBT, and who refuse or are ineligible for radical cystectomy. BCG unresponsive is defined as occurrence of any one of the following in NMIBC patients after adequate BCG therapy (at least 5 full dose inductions and at least 2 maintenance instillations of BCG):\n\n      * Persistent or recurrent CIS within 12 months after adequate BCG therapy, with or without recurrence of high-grade Ta or T1 tumors;\n      * Recurrence of high-grade Ta\u002FT1 tumors within 6 months after adequate BCG therapy (disease-free);\n      * Recurrence of high-grade tumors at the first assessment during maintenance therapy after adequate BCG induction.\n   2. Patients who have not received BCG therapy after prior TURBT, including the following three scenarios:\n\n      * NMIBC patients who failed intravesical chemotherapy, and who refuse or are ineligible for repeat postoperative intravesical chemotherapy or BCG instillation by the investigator.\n      * HR-NMIBC patients who have not received BCG therapy after TURBT, and who refuse or are ineligible for BCG instillation as determined by the investigator. Ineligibility for BCG includes, but is not limited to: active tuberculosis, severe hematuria, recent traumatic catheterization, symptomatic urinary tract infection, immunodeficiency or impairment (e.g., AIDS, patients receiving immunosuppressants or radiotherapy), BCG hypersensitivity, etc.\n      * HR-NMIBC patients who received prior BCG therapy but discontinued treatment for more than 3 years before enrollment.\n5. Participants must have undergone TURBT within 12 weeks prior to signing informed consent and meet the following criteria:\n\n   1. For papillary lesions (Ta and T1 stages): complete resection of all visible papillary lesions, with negative urine cytology (including atypical findings).\n   2. For patients with CIS: residual unresectable CIS lesions are permitted.\n6. Sufficient bone marrow reserve and adequate hepatic\u002Frenal function.\n7. Eastern Cooperative Oncology Group (ECOG) performance status score 0-1.\n\nExclusion Criteria:\n\n1. Histopathologically confirmed muscle invasive (pathologic T stage ≥ T2), locally advanced, unresectable, or metastatic urothelial carcinoma.\n2. Urothelial carcinoma outside the bladder (e.g., urethra, ureter, renal pelvis) unless radically resected with no disease recurrence for \\> 2 years.\n3. History of other primary solid tumors, except:\n\n   1. Radically treated solid tumor with no activity for ≥5 years before enrollment and low recurrence risk;\n   2. adequately treated non-melanoma skin cancer (e.g., basal cell carcinoma, squamous cell carcinoma) or lentigo maligna with no evidence of recurrence;\n   3. adequately treated carcinoma in situ (e.g., cervical, ductal carcinoma in situ of breast) with no evidence of recurrence.\n4. Has received or is receiving any of the following treatments:\n\n   1. Regular intravesical chemotherapy (gemcitabine, pirarubicin, mitomycin, etc.) or BCG instillation intolerance following TURBT\u002Fbladder biopsy before enrollment.\n   2. Pelvic radiotherapy within 4 weeks prior to first study treatment. Patients with last radiotherapy \\>4 weeks prior and no confirmed radiation cystitis may be enrolled.\n   3. Major surgery (TURBT is not considered major surgery) within 4 weeks before first study treatment, or incomplete recovery from postoperative complications.\n   4. Systemic chemotherapy, small-molecule targeted therapy, or investigational therapy within 4 weeks before first study treatment.\n5. Residual toxicity ≥ Grade 2 per CTCAE version 6.0 from prior therapy (surgery, intravesical instillation, etc.), except alopecia, pigmentation.\n6. Bladder or urethral anatomical features that may interfere with HS-10566 implantation, retention, or removal (e.g., urethral stricture, bladder diverticulum, total urinary incontinence, bladder perforation).\n7. Current or history of clinically significant polyuria (24-hour urine output \\>4000 mL).\n8. Requirement for long-term indwelling urinary catheter during study treatment (e.g., urinary obstruction).\n9. Intermittent catheterization for clinical indications is allowed.",{"count":295,"type":22},180,[59,173],"This is a multicenter, open-label, Phase I\u002FII clinical study evaluating the safety, efficacy, tolerability, and pharmacokinetic\u002Fpharmacodynamic (PK\u002FPD) profiles of HS-10566 in patients with high-risk non-muscle-invasive bladder cancer who are ineligible for or refuse radical cystectomy. The study comprises two distinct phases: a dose exploration phase and a proof-of-concept phase.",[299],"High-risk Non-muscle-invasive Bladder Cancer",[301],"High-risk Non-muscle-invasive Bladder Neoplasms Administration, Intravesical","2026-03-08",{"date":304,"type":39},"2026-03-13",{"date":306,"type":22},"2026-06-10",{"date":308,"type":22},"2029-04-30",{"name":45,"class":46},2,{"id":312,"slug":313,"hasResults":12,"nctId":314,"briefTitle":315,"officialTitle":316,"acronym":4,"eligibilityCriteria":317,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":145,"enrollmentInfo":318,"targetDuration":4,"studyType":23,"phases":320,"briefSummary":321,"conditions":322,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":324,"startDateStruct":326,"completionDateStruct":328,"leadSponsor":330,"locationsCount":4},"100624847","phase-1-a-phase-ib-study-of-hs-10504-combined-therapy-in-nsclc-100624847","NCT07414953","A Phase Ib Study of HS-10504 Combined Therapy in NSCLC","A Phase Ib Study of the Safety, Efficacy, Pharmacokinetics, and Immunogenicity of HS-10504 Combined Therapy in Advanced Non-small Cell Lung Cancer Patients","Inclusion Criteria:\n\n* Cohort1:participants with EGFR mutation advanced stage NSCLC，disease progression on or after prior treatment；\n* Cohort2:participants with MET position advanced stage NSCLC，disease progression on or after prior treatment；\n* With at least 1 target lesion according to RECIST 1.1.\n* Appropriate organ function\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-1 and no deterioration within 2 weeks prior to the first dose.\n* Minimum expected survival longer than 12 weeks\n* Female subjects of childbearing potential are willing to take appropriate contraceptive measures and should not breastfeed from signing the informed consent form (ICF) through 6 months after the last dose; male subjects are willing to use barrier contraception (i.e., condom) from signing the ICF through 6 months after the last dose.\n* Voluntarily participate in this clinical trial, understand the study procedures, and be able to sign written informed consent form.\n\nExclusion Criteria:\n\n* Insufficient wash out duration of prior systemic anticancer therapy\n* Local radiotherapy within 2 weeks prior to first dose of investigational drug\n* Pleural\u002Fabdominal effusion requires clinical intervention\n* Major surgery within 4 weeks prior to first dose of investigational drug\n* History of drugs may prolong QT interval\n* Have any grade ≥ 2 residual toxicity according to Common Terminology Criteria for Adverse Events (CTCAE, version 5.0) from prior anti-tumor therapy (except alopecia and residual neurotoxicity).\n* Presence of brain metastasis or carcinomatous meningtitis\n* History of other primary malignancies\n* Significant, uncontrolled, or active cardiovascular diseases\n* Severe or poorly controlled diabetes\n* Extremely obesity or emaciation\n* Clinically significant bleeding symptoms or obvious bleeding tendency within 1 month prior to the first dose\n* Severe arteriovenous thrombotic events (e.g., deep venous thrombosis, pulmonary embolism) within 3 months prior to the first dose\n* Severe infection within 4 weeks\n* History of systemic glucocorticoids over 28 days prior to first dose of investigational drug\n* Presence of known active infectious diseases,\n* Presence of hepatic encephalopathy, Hepantorenal Syndrome\n* Presence or history of confirmed or suspected ILD;\n* Prior history of significant neurological or mental disorders, including conditions that interfere with assessment, such as epilepsy, dementia, or major depressive disorder.\n* Past history of severe allergy, or history of hypersensitivity to any active or inactive ingredient of investigational drugs.\n* Presence of any conditions that jeopardize subject safety or interfere with study assessments as judged by the investigator.",{"count":319,"type":22},400,[59],"This is a multi-center, open-label, phase I study to evaluate the safety, efficacy, pharmacokinetics (PK), and immunogenicity of HS-10504 combined therapy in subjects with locally advanced or metastatic non-small cell lung cancer (NSCLC).",[323],"Lung Cancer",{"date":325,"type":39},"2026-02-17",{"date":327,"type":22},"2026-03-30",{"date":329,"type":22},"2028-11-30",{"name":45,"class":46},{"id":332,"slug":333,"hasResults":12,"nctId":334,"briefTitle":335,"officialTitle":336,"acronym":4,"eligibilityCriteria":337,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":338,"targetDuration":4,"studyType":23,"phases":340,"briefSummary":341,"conditions":342,"keywords":344,"overallStatus":229,"whyStopped":4,"lastUpdateSubmitDate":348,"lastUpdatePostDateStruct":349,"startDateStruct":351,"completionDateStruct":353,"leadSponsor":355,"locationsCount":73},"100551520","phase-1-a-study-of-hs-10504-in-patients-with-advanced-or-metastatic-non-small-cell-lung-cancernsclc-100551520","NCT06461156","A Study of HS-10504 in Patients With Advanced or Metastatic Non-Small-Cell Lung Cancer(NSCLC)","A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HS-10504 in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC）","Inclusion Criteria:\n\n* Males or females, aged ≥ 18 years.\n* Subjects with histologically or cytologically confirmed locally advanced or metastatic NSCLC\n* Progressive disease on or after prior treatment with EGFR-TKIs.\n* Enrollment will be restricted to participants with evidence of EGFR-positive in tumor as determined by local or central testing.\n* At least 1 target lesion according to RECIST 1.1.\n* ECOG PS score: 0-1.\n* Estimated life expectancy\\> 12 weeks.\n* Men or women should be using adequate contraceptive measures throughout the study.\n* Women must have the evidence of non-childbearing potential.\n* Signed and dated Informed Consent Form.\n\nExclusion Criteria:\n\n* Subjects with known oncogenic driver genes other than EGFR.\n* Subjects with mixed cell histologic or with phenotypic transformation.\n* Treatment with any of the following:\n\n  1. Prior or concurrent treatment with fourth-generation EGFR tyrosine kinase inhibitors.\n  2. Cytotoxic chemotherapy, any other investigational drugs, traditional Chinese medicine with anti-tumor indications, or other anti-tumor drugs within 14 days prior to the first dose of HS-10504 or require continued treatment with these drugs during the study.\n  3. Any local radiotherapy 2 weeks prior to the first dose of study treatment; have received irradiation of more than 30% of bone marrow prior to the first dose\n  4. Uncontrolled pleural effusion or ascites or pericardial effusion.\n  5. Major surgery within 4 weeks before the first dose.\n  6. CNS metastases with symptomatic or active progression.\n* Subjects who have any grade ≥2 residual toxicities from prior therapies.\n* Subjects who have history of other primary malignancies.\n* Inadequate bone marrow reserve or hepatic and renal functions.\n* Subjects with severe or poorly controlled diabetes, cardiovascular diseases or hypertension; subjects with severe arteriovenous thrombotic events, severe infection, clinically significant bleeding symptoms or clinically significant gastrointestinal dysfunction.\n* Hypersensitivity to any ingredient of HS-10504.\n* Moderate to severe pulmonary diseases.\n* Prior history of significant neurological or mental disorders.\n* Women who are breastfeeding or pregnant or planned to be pregnant during the study period.\n* Unlikely to comply with study procedures, restrictions, and requirements in the opinion of the investigator.\n* Any disease or condition that, in the opinion of the investigator, would compromise subject safety or interfere with study assessments.",{"count":339,"type":22},230,[59],"HS-10504 is a fourth-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor targeting EGFR C797S mutation. This study will evaluate the safety, tolerability, pharmacokinetics and efficacy of HS-10504 in Chinese locally advanced or metastatic NSCLC.",[343],"Locally Advanced or Metastatic NSCLC",[345,346,347],"locally advanced or metastatic NSCLC","EGFR C797S","HS-10504","2025-09-11",{"date":350,"type":39},"2025-09-17",{"date":352,"type":39},"2025-07-22",{"date":354,"type":22},"2027-03-31",{"name":45,"class":46},{"id":357,"slug":358,"hasResults":12,"nctId":359,"briefTitle":360,"officialTitle":361,"acronym":4,"eligibilityCriteria":362,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":363,"targetDuration":4,"studyType":23,"phases":365,"briefSummary":366,"conditions":367,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":369,"lastUpdatePostDateStruct":370,"startDateStruct":372,"completionDateStruct":374,"leadSponsor":376,"locationsCount":73},"100604975","phase-3-a-phase-3-study-of-hs-20094-in-patients-with-t2dm-inadequately-controlled-with-diet-and-exercise-alone-100604975","NCT07156500","A Phase 3 Study of HS-20094 in Patients With T2DM Inadequately Controlled With Diet and Exercise Alone","A Multicenter, Randomized, Double-Blind, Placebo- Parallel Controlled, Phase III Study to Evaluate the Efficacy and Safety of HS-20094 Injection in Subjects With Type 2 Diabetes, Inadequately Controlled With Diet and Exercise Alone","Inclusion Criteria:\n\n1. Males and females, Age ≥18 years at the time of signing informed consent.\n2. Diagnosed with type 2 diabetes mellitus (T2DM) for at least 90 days prior to day of screening.\n3. Treatment with Diet and Exercise alone at least 90 days prior to day of screening.\n4. 7.5% ≤ HbA1c ≤10.5% at screening.\n\nExclusion Criteria:\n\n1. Uncontrollable hypertension(with or without antihypertensive treatment) : systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg at screening.\n2. Diagnosed or suspected with type 1 diabetes mellitus, special types of diabetes or secondary diabetes.\n3. History of significant hematological disorders (e.g., sickle cell disease, hemolytic anemia, myelodysplastic syndrome, etc.) or other conditions causing hemolysis or instability of red blood cells (e.g., malaria, hypersplenism, etc.).\n4. Presence of an endocrine disorder or history that may significantly affect bady weight(e.g., Cushing's syndrome, hypothyroidism or hyperthyroidism, except hypothyroidism if thyroid hormone replacement dose has been stable for at least 6 months) ；\n5. Severe infection, severe trauma, or moderate-to-major surgery within 4 weeks before screening.\n6. Participated in clinical trials of any drug or medical device within 12 weeks prior to screening, and participation in clinical trials is defined as signing informed consent and using investigational drugs (including placebo) or investigational medical devices; Or is still in the trial drug within 5 half-lives (whichever is Longer).",{"count":364,"type":22},204,[25],"This is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study to evaluate the efficacy and safety of HS-20094 injection in subjects with type 2 diabetes who have inadequate glycemic control with diet and exercise alone. The primary objective of this study is to evaluate the effectiveness of HS-20094 compared to placebo in controlling blood glucose levels after 44 weeks and 52 weeks treatment.",[368],"Type 2 Diabetes","2025-08-28",{"date":371,"type":39},"2025-09-05",{"date":373,"type":22},"2025-09-30",{"date":375,"type":22},"2027-05-30",{"name":45,"class":46},{"id":378,"slug":379,"hasResults":12,"nctId":380,"briefTitle":381,"officialTitle":382,"acronym":4,"eligibilityCriteria":383,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":384,"targetDuration":4,"studyType":23,"phases":386,"briefSummary":387,"conditions":388,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":369,"lastUpdatePostDateStruct":389,"startDateStruct":390,"completionDateStruct":391,"leadSponsor":392,"locationsCount":310},"100604978","phase-3-a-phase-3-study-of-hs-20094-in-patients-with-t2dm-100604978","NCT07156539","A Phase 3 Study of HS-20094 in Patients With T2DM","A Study of HS-20094 Versus Dulaglutide Once Weekly as Add-on Therapy to Metformin Monotherapy or in Combination With SGLT2 Inhibitors in Participants With Type 2 Diabete","Inclusion Criteria:\n\n1. Males and females, Age ≥18 years at the time of signing informed consent.\n2. Stable daily dose(s) for ≥90 days prior to screening of : 1) Any metformin formulations ≥1500 mg daily or maximum tolerated (≥1000mg daily). 2) Any metformin formulations ≥1500 mg daily or maximum tolerated (≥1000mg daily) with one type of SGLT-2 inhibitors;\n3. Glycated hemoglobin was 7.5% ≤HbA1c ≤11.0%;\n4. BMI ≥ 23 kg\u002Fm2.\n\nExclusion Criteria:\n\n1. Uncontrollable hypertension(with or without antihypertensive treatment) : systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg at screening.\n2. Diagnosed or suspected with type 1 diabetes mellitus, special types of diabetes or secondary diabetes.\n3. History of significant hematological disorders (e.g., sickle cell disease, hemolytic anemia, myelodysplastic syndrome, etc.) or other conditions causing hemolysis or instability of red blood cells (e.g., malaria, hypersplenism, etc.).\n4. Presence of an endocrine disorder or history that may significantly affect bady weight(e.g., Cushing's syndrome, hypothyroidism or hyperthyroidism, except hypothyroidism if thyroid hormone replacement dose has been stable for at least 6 months) ；\n5. Severe infection, severe trauma, or moderate-to-major surgery within 4 weeks before screening.\n6. Participated in clinical trials of any drug or medical device within 12 weeks prior to screening, and participation in clinical trials is defined as signing informed consent and using investigational drugs (including placebo) or investigational medical devices; Or is still in the trial drug within 5 half-lives (whichever is Longer).",{"count":385,"type":22},546,[25],"The study is being conducted to evaluate the efficacy and safety of HS-20094 once weekly (QW) in subjects with type 2 diabetes mellitus not adequately controlled with metformin monotherapy or in combination with SGLT2 inhibitors compared to Dulaglutide QW for 44 weeks and 52 weeks.",[368],{"date":371,"type":39},{"date":373,"type":22},{"date":375,"type":22},{"name":45,"class":46},{"id":394,"slug":395,"hasResults":12,"nctId":396,"briefTitle":397,"officialTitle":398,"acronym":4,"eligibilityCriteria":399,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":400,"targetDuration":4,"studyType":23,"phases":401,"briefSummary":402,"conditions":403,"keywords":4,"overallStatus":229,"whyStopped":4,"lastUpdateSubmitDate":405,"lastUpdatePostDateStruct":406,"startDateStruct":408,"completionDateStruct":410,"leadSponsor":412,"locationsCount":413},"100603007","phase-1-a-study-of-aumolertinib-in-european-participants-with-non-small-cell-lung-cancer-100603007","NCT07130916","A Study of Aumolertinib in European Participants With Non-Small Cell Lung Cancer","A Phase 1, Open-Label, Multiple-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Aumolertinib in European Participants With Locally Advanced or Metastatic, EGFR-mutated Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n1. Male or female European participants (inhabitant of a European country and of European descent) must be ≥ 18 years of age, at the time of signing the informed consent.\n2. Histological or cytological confirmation diagnosis of newly diagnosed locally advanced (clinical stage IIIB or IIIC) or metastatic (clinical stage IVA or IVB) NSCLC or recurrent NSCLC (per The Eighth Edition of The American Joint Committee on Cancer \\[AJCC\\] Cancer Staging Manual in Lung Cancer), not amenable to curative surgery or definitive radiotherapy with or without chemotherapy.\n\n   NOTE: if small cell elements are present, the participant is ineligible.\n3. Prior anti-tumor systemic therapy. Participant must fulfill one of below:\n\n   1. Participants who have not received any prior anti-tumor systemic therapy, and the tumor must harbor at least one of the EGFR mutations (ex19del or L858R).\n   2. Participants who have received prior neoadjuvant, adjuvant therapies with curative intent for nonmetastatic disease must have completed treatment for at least 12 months prior to the development of recurrent or metastatic disease, and the tumor must harbor at least one of the EGFR mutations (ex19del or L858R).\n   3. Participant who only received one line of first- or second-generation EGFR-TKI in the locally advanced or metastatic setting and have documented radiological progression prior to enrolling in the study, and the tumor must harbor EGFR T790M mutation.\n4. Confirmation that the tumor harbors at least one of the EGFR mutations (ex19del, L858R, or T790M) using a clinically validated assay in a licensed laboratory with applicable local accreditation based on tumor tissue and\u002For circulating tumor deoxyribonucleic acid (ctDNA) in blood.\n5. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-1 and no deterioration in the previous two weeks with a minimum life expectancy of 12 weeks.\n6. Participants must have evaluable disease. At least one measurable (not previously irradiated) and\u002For non-measurable lesions per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (Appendix 6) that can be accurately assessed at baseline and suitable for repeated assessments by computed tomography (CT) or magnetic resonance imaging (MRI) scans. If only one measurable lesion exists, it is acceptable to be used (as a target lesion \\[TL\\]) as long as it has not been previously irradiated and as long as it has not been biopsied within 14 days of the baseline tumor assessment scans.\n7. Adequate bone marrow reserve or organ function without blood transfusion or growth factor support ≤ 14 days before sample collection at screening as demonstrated by any of the following laboratory values:\n\n   1. Absolute neutrophil count ≥ 1.5 × 109\u002FL;\n   2. Platelet count ≥ 80 × 109\u002FL;\n   3. Hemoglobin ≥ 90 g\u002FL;\n   4. ALT ≤ 2.5 × upper limit of normal (ULN) if no demonstrable liver metastases or ≤ 5 × ULN in the presence of liver metastases;\n   5. AST ≤ 2.5 × ULN if no demonstrable liver metastases or ≤ 5 × ULN in the presence of liver metastases;\n   6. Total bilirubin (TBL) ≤ 1.5 × ULN if no liver metastases or ≤ 3 × ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinaemia) or liver metastases;\n   7. Creatinine ≤ 1.5 × ULN concurrent with creatinine clearance ≥ 50 mL\u002Fmin (measured or calculated by Cockcroft and Gault equation);\n   8. The confirmation of creatinine clearance is only required when creatinine is ≤ 1.5 × ULN;\n   9. International normalized ratio (INR) ≤ 1.5;\n   10. Activated partial thromboplastin time ≤ 1.5 ULN;\n8. Contraceptive use by men and women must be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n\n   NOTE: The reliability of sexual abstinence for male and\u002For female enrollment eligibility needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the participant. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post ovulation methods) and withdrawal are not acceptable methods of contraception.\n\n   Male Participants:\n\n   • A male participant must agree to use a highly effective contraception as detailed in Appendix 4 of this protocol from screening to three months after the last dose of study intervention.\n\n   Female Participants:\n\n   • A female participant is eligible to participate if she has a negative pregnancy test no later than 72 hours prior to start of dosing if of childbearing potential, not breastfeeding from screening to three months after the last dose of the study intervention, and at least one of the following conditions applies:\n   * Not a woman of childbearing potential (WOCBP) as defined in Appendix 4. OR\n   * A WOCBP who agrees to follow the contraceptive guidance in Appendix 4 from screening to three months after the last dose of study intervention and should not be breastfeeding from screening to three months after the last dose of the study intervention.\n9. Participant is capable of giving signed informed consent as described in Appendix 1, Section 10.1.3 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n\nExclusion Criteria:\n\n1. Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 at the time of starting study intervention with the exception of alopecia and Grade 2 neurotoxicity related to prior platinum-therapy.\n2. History of another primary malignancy except for the malignancy treated with curative intent with no known active disease ≤ 5 years before the first dose of study intervention and of low potential risk for recurrence. Exceptions include, but are not limited to, adequately resected non melanoma skin cancer, and curatively treated in situ disease.\n3. Spinal cord compression or brain metastases unless asymptomatic, stable, and not requiring steroids for at least four weeks prior to start of study intervention.\n4. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding within two weeks prior to the first dose of study intervention, active infection (e.g., active HBV infection, HCV infection), or HIV infection, which in the Investigator's opinion makes it undesirable for the participant to participate in the study or which would jeopardise compliance with the protocol.\n5. Any of the following cardiac criteria: mean resting corrected QT (QT; the time from the start of the Q wave to the end of the T wave in an ECG) interval corrected for heart rate using Fridericia's correction factor (QTcF) \\> 470 ms obtained from three ECGs; any clinically important abnormalities in rhythm, conduction or morphology of resting ECG e.g., complete left bundle branch block, third degree heart block, second degree heart block, PR interval \\> 250 ms; any factors that increase the risk of corrected QT (QTc) prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under age of 40 or any concomitant medication known to prolong the QT interval; Left ventricular ejection fraction (LVEF) ≤ 40%.\n6. Past medical history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD.\n7. Refractory nausea, vomiting, or chronic GI disorders; Participants unable to swallow oral medication or participants with GI disorders or significant GI resection likely to interfere with the absorption of study intervention.\n8. Participant has any disease or condition that, in the judgment of the physician, may increase the risk to the safety or interfering with study assessments.\n9. Participant with a known hypersensitivity to study intervention, structural analog, or any of the excipients of the products.\n10. Received any of the following treatments:\n\n    1. Treatment with a first- or second-generation EGFR-TKI (e.g., erlotinib or gefitinib) within 8 days of the first dose of study intervention or 5 half-lives, whichever is the longer.\n    2. Treatment with prior third-generation EGFR-TKI (e.g., osimertinib).\n    3. Any cytotoxic chemotherapy, investigational agents or other anticancer drugs from a previous treatment regimen or clinical study taken within 14 days of the first dose of study intervention or 5 half lives, whichever is longer.\n    4. Treatment with medications known to be potent strong inhibitors or inducers of CYP3A4 or narrow therapeutic index drugs for CYP3A4 sensitive substrates (see Appendix 7) within 7 days of the first dose of study intervention or 5 half-lives, whichever is the longer.\n    5. Major surgery (excluding placement of vascular access) within four weeks of the first dose of study intervention.\n    6. Radiotherapy with a limited field of radiation for palliation within one week prior to the first dose of study intervention or receiving radiation with more than 30% of the bone marrow or with a wide field of radiation within four weeks prior to the first dose of study intervention.\n11. Participants participated in any interventional clinical study or had been treated with any investigational drugs within 28 days or 5 half-lives, whichever is longer, before Screening Visit.\n\n    Other Exclusion Criteria\n12. Participant who, in the judgment of the Investigator, may have poor compliance with the procedures, limitations, and requirements of the study and are not suitable for enrollment.",{"count":194,"type":22},[59],"This is a Phase 1, open-label, multicenter, multiple-dose study to evaluate aumolertinib in European participants with a confirmed diagnosis of activating EGFR mutation positive (EGFRm+) locally advanced or metastatic NSCLC.",[404],"Non-Small Cell Lung Cancer","2025-08-18",{"date":407,"type":39},"2025-08-19",{"date":409,"type":39},"2024-12-05",{"date":411,"type":22},"2027-12-31",{"name":45,"class":46},6,{"id":415,"slug":416,"hasResults":12,"nctId":417,"briefTitle":418,"officialTitle":419,"acronym":4,"eligibilityCriteria":420,"healthyVolunteers":54,"sex":17,"minAge":18,"maxAge":55,"enrollmentInfo":421,"targetDuration":4,"studyType":23,"phases":423,"briefSummary":424,"conditions":425,"keywords":427,"overallStatus":229,"whyStopped":4,"lastUpdateSubmitDate":428,"lastUpdatePostDateStruct":429,"startDateStruct":431,"completionDateStruct":433,"leadSponsor":435,"locationsCount":436},"100581161","phase-1-evaluate-the-safety-and-pharmacokineticspharmacodynamics-of-hs-20118-100581161","NCT06846710","Evaluate the Safety and Pharmacokinetics\u002FPharmacodynamics of HS-20118","A Phase I Clinical Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of HS-20118 in Adult Participants","Inclusion Criteria:\n\nFor the SAD study:\n\n1. Healthy adults aged 18-45 years (inclusive) at the time of signing the informed consent form;\n2. Male participants weighing ≥ 50 kg and female participants weighing ≥ 45 kg, both ≤ 110 kg; body mass index (weight\u002Fsquare of height (kg\u002Fm2)) within the range of 18-28 kg\u002Fm2 (inclusive);\n3. Normal results or abnormal results but without clinical significance in comprehensive examinations, including general physical examination, vital signs, laboratory tests, 12-lead ECG, abdominal color Doppler ultrasound, and chest X-ray from the frontal and lateral position ;\n\nFor the MAD study:\n\n1. Male or female participants aged 18-65 years (inclusive) at the time of signing the informed consent form;\n2. Male participants weighing ≥ 50 kg and female participants weighing ≥ 45 kg, both ≤ 110 kg;\n3. Chronic plaque psoriasis for at least 6 months with or without psoriatic arthritis;\n\nExclusion Criteria:\n\nFor the SAD study:\n\n1. Participants with immune-related diseases and medical history at screening;\n2. Participants with a history of drug or other allergies who are considered by the investigator to be at high risk for participating in this study, or who may be allergic to the investigational medicinal product or any component of the investigational medicinal product as judged by the investigator;\n3. History of drug abuse within the past 5 years or use of illicit drugs within 3 months before the study; or positive for urine drug screening;\n\nFor the MAD study:\n\n1. Guttate psoriasis, pustular psoriasis, erythrodermic psoriasis, drug-induced psoriasis, or other diseases that affect the treatment results;\n2. Current use of illicit drugs or prior use of illicit drugs within the specific time periods;\n3. Known history of recurrent or chronic infections, or prior history of chronic or recurrent infections, including but not limited to: chronic renal infection, chronic chest infection (e.g., bronchiectasis), symptomatic urinary tract infection, and open, draining, or infected skin wounds; history of serious infections (e.g., sepsis, pneumonia, and pyelonephritis), or hospitalization or treatment with intravenous antibiotics for infections within 2 months before screening;",{"count":422,"type":22},132,[59],"The study will be conducted in 2 parts (SAD for Part 1 and MAD for Part2). Part 1 is a single-center, randomized, double-blind, placebo-controlled, SAD study to evaluate the safety, tolerability, immunogenicity, and PK of HS-20118 after a single oral dose in healthy participants.\n\nPart 2 is a multi-center, randomized, double-blind, placebo-controlled, MAD study to evaluate the safety, tolerability, immunogenicity, PK, and PD of HS-20118 after multiple oral doses in patients with moderate to severe plaque psoriasis .",[426],"Psoriasis",[426],"2025-08-04",{"date":430,"type":39},"2025-08-07",{"date":432,"type":39},"2025-05-02",{"date":434,"type":22},"2027-02-28",{"name":45,"class":46},9,{"id":438,"slug":439,"hasResults":12,"nctId":440,"briefTitle":441,"officialTitle":442,"acronym":4,"eligibilityCriteria":443,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":444,"targetDuration":4,"studyType":23,"phases":446,"briefSummary":447,"conditions":448,"keywords":4,"overallStatus":229,"whyStopped":4,"lastUpdateSubmitDate":450,"lastUpdatePostDateStruct":451,"startDateStruct":453,"completionDateStruct":455,"leadSponsor":457,"locationsCount":73},"100600472","phase-1-study-of-hs-10516-combination-therapy-in-patients-with-advanced-renal-cell-carcinoma-100600472","NCT07097935","Study of HS-10516 Combination Therapy in Patients With Advanced Renal Cell Carcinoma","A Phase Ib\u002FII Clinical Study Evaluating the Safety, Efficacy, Tolerability, and Pharmacokinetics of HS-10516 Combination Therapy in Patients With Advanced Renal Cell Carcinoma","Inclusion Criteria:\n\n1. Men or women aged more than or equal to (≥) 18 years.\n2. Histologically confirmed unresectable, locally advanced or metastatic clear cell renal cell carcinoma (ccRCC) with disease progression during or after receiving ≥1 prior line of systemic therapy in the advanced setting.\n3. Patients have at least one target lesion according to RECEST 1.1. The requirements for target lesions are: measurable lesions without local treatment such as irradiation, or with definite progress after local treatment, with the longest diameter ≥ 10 mm in the baseline period (in case of lymph nodes, the shortest axis ≥ 15 mm is required). Patients with only brain and\u002For bone lesions as target lesions will not be included.\n4. ECOG performance status was 0-1 and did not deteriorate in the previous 2 weeks.\n5. Estimated life expectancy greater than (\\>) 12 weeks.\n6. Reproductive-age women agree to use adequate contraception and cannot breastfeed while participating in this study and for a period of 12 months after the last dose. Likewise, men also consent to use adequate contraceptive method within the same time limit.\n7. Females must have the evidence of non-childbearing potential\n8. Sign informed consent form.\n\nExclusion Criteria:\n\n1. Prior or Current Treatments:\n\n   1. Previous or current use of hypoxia-inducible factor inhibitors.\n   2. Previous or current use of lenvatinib.\n   3. Use of Chinese herbal medicine with antitumor indications within 2 weeks prior to the first dose or requirement for such treatment during the study.\n   4. Administration of cytotoxic chemotherapy or other systemic antitumor therapies (e.g., endocrine therapy, molecular targeted therapy) within 2 weeks or 5 half-lives (whichever is shorter) prior to the first dose, or requirement for such treatments during the study.\n   5. Use of large-molecule antitumor drugs within 4 weeks prior to the first dose or requirement for such treatment during the study.\n   6. Use of CYP2C19 strong inhibitors\u002Finducers or narrow therapeutic index sensitive substrates within 7 days prior to the first dose, or requirement for continued use during the study.\n   7. Local radiotherapy (except brain radiotherapy; see Criterion 6) within 2 weeks prior to the first dose, or \\>30% bone marrow irradiation\u002Flarge-field radiotherapy within 4 weeks prior to the first dose.\n   8. Major surgery (e.g., craniotomy, thoracotomy, laparotomy; Grade 3\u002F4 per Chinese Medical Technical Clinical Application Regulations) within 4 weeks prior to the first dose.\n   9. Participation in other interventional clinical trials within 4 weeks prior to the first dose or within 5 half-lives of investigational drugs (whichever is longer).\n2. Resting pulse oximetry \\\u003C92% at screening.\n3. Severe pulmonary dysfunction requiring intermittent\u002Flong-term oxygen therapy.\n4. Unresolved Grade \\>1 toxicities from prior anti-tumor therapy (per CTCAE v5.0).\n5. History of second primary malignancy.\n6. Known or suspected active CNS metastases\u002Fleptomeningeal disease.\n7. Inadequate bone marrow reserve or serious organ dysfunction.\n8. Severe, uncontrolled, or active cardiovascular disease.\n9. Severe or poorly controlled diabetes.\n10. Severe or poorly controlled hypertension.",{"count":445,"type":22},104,[59,173],"This is a multicenter, open-label, Phase Ib\u002FII clinical study evaluating the safety, efficacy, tolerability, and pharmacokinetic\u002Fpharmacodynamic (PK\u002FPD) profiles of HS-10516 in combination with lenvatinib in patients with advanced clear cell renal cell carcinoma (ccRCC) who have progressed after receiving at least one prior line of systemic therapy. The study comprises two distinct phases: a dose exploration phase and a proof-of-concept phase.",[449],"Advanced Clear Cell Renal Cell Carcinoma","2025-07-30",{"date":452,"type":39},"2025-08-01",{"date":454,"type":39},"2025-07-10",{"date":456,"type":22},"2028-07-10",{"name":45,"class":46},{"id":459,"slug":460,"hasResults":12,"nctId":461,"briefTitle":462,"officialTitle":463,"acronym":4,"eligibilityCriteria":464,"healthyVolunteers":54,"sex":17,"minAge":18,"maxAge":55,"enrollmentInfo":465,"targetDuration":4,"studyType":23,"phases":467,"briefSummary":468,"conditions":469,"keywords":4,"overallStatus":229,"whyStopped":4,"lastUpdateSubmitDate":471,"lastUpdatePostDateStruct":472,"startDateStruct":473,"completionDateStruct":475,"leadSponsor":476,"locationsCount":73},"100597375","phase-1-a-study-of-hs-20094-in-overweight-or-obese-participants-100597375","NCT07057674","A Study of HS-20094 in Overweight or Obese Participants","A Bioequivalence Study of HS-20094 Multi-dose Pre-filled Injection and HS-20094 Single-dose Pre-filled Injection in Overweight or Obese Participants","Inclusion Criteria:\n\n1. Able to understand the procedures and methods of this study, willing to strictly adhere to the clinical study protocol to complete this study, and voluntarily sign the informed consent form;\n2. Adult male or female participants (aged 18-65 years (inclusive), calculated based on the date of signing the informed consent form);\n3. Body mass index (BMI) ≥24.0 kg\u002Fm2 (BMI = weight (kg) \u002F height2 (m2)); body weigh ≥45 kg for female participants and ≥50 kg for male participants.\n4. Self-reported diet\u002Fexercise control alone for at least 12 weeks prior to screening, with a weight change of ≤5% in the past 12 weeks (based on self-report); calculation formula for weight change: (highest weight - lowest weight within 12 weeks prior to screening) ∕ highest weight \\* 100%;\n5. Agree to take effective contraceptive measures from the signing of the informed consent form until 8 weeks after the last dose, and have no plans for conception or sperm\u002Fegg donation during this period (only non-drug contraceptive measures are permitted during the study).\n\nExclusion Criteria:\n\nParticipants with any of the following examination abnormalities at screening:\n\n1. Laboratory test results meet any of the following criteria (if there is a clear reason for retesting, one re-examination can be conducted within the time window of the screening period, and the results of this re-examination will be used as the basis for screening):\n\n   * HemoglobinA1c (HbA1c) ≥6.5% or fasting plasma glucose ≥7.0 mmol\u002FL;\n\n     * Fasting plasma glucose \\\u003C2.8 mmol\u002FL;\n\n       * Alanine aminotransferase \\> 3 × ULN, or aspartate aminotransferase \\> 3 × ULN, or total bilirubin \\> 1.5 × ULN;\n\n         * Triglyceride \\>500 mg\u002FdL (5.64 mmol\u002FL);\n\n           * Estimated glomerular filtration rate (absolute eGFR) based on the CKD-EPI equation \\\u003C60 mL\u002Fmin;\n\n             * Serum calcitonin level ≥50 ng\u002FL; ⑦ Thyroid-stimulating hormone \\>6.0 mIU\u002FL or \\\u003C0.4 mIU\u002FL;\n\n               ⑧ Blood amylase or blood lipase \\>2×ULN;\n               * Prothrombin time (PT)-international normalized ratio (INR) exceeds the upper limit of normal, and the investigator determines the abnormality to be clinically significant, making it unsuitable for the participant to be enrolled; ⑩ Hemoglobin \\\u003C110 g\u002FL (male) or \\\u003C100 g\u002FL (female); ⑪ Positive test result for any one or more of the following items: hepatitis B surface antigen, hepatitis C antibody, HIV antibody\u002Fp24 antigen, or Treponema pallidum antibody;\n\n   Presence of any of the following diseases or medical history prior to screening or randomization:\n2. Participants who currently have or with history of severe diseases involving nervous system, psychiatric system, digestive system, circulatory system, respiratory system, urinary system, etc., or have newly developed diseases before administration of the investigational product, and therefore are deemed by the investigator as unsuitable for participation in this study;\n3. Past history or ultrasound findings during screening period include any of the following conditions: medical history of chronic pancreatitis, acute pancreatitis, cholecystitis, or symptomatic\u002Ftreatment-requiring gallbladder stones (except for participants who have undergone cholecystectomy but are deemed eligible for enrollment by the investigator);\n4. Participants with a history or family history of thyroid C-cell tumors or multiple endocrine neoplasia type 2;\n5. Participants with a history of metabolic disorders (such as unexplained recurrent hypoglycemia) who are deemed unsuitable for participation in this study upon the evaluation by the investigator;\n6. Presence of endocrine diseases or medical history that may significantly affect weight (e.g., Cushing's syndrome, hypothyroidism, hyperthyroidism, etc., except for hypothyroidism if thyroid hormone replacement dosage has been stabilized for at least 6 months), or obesity due to a single gene mutation or hereditary obesity syndrome, etc.;\n7. Presence of autoimmune disorders and planned use of systemic glucocorticoid therapy or immunosuppressive therapy during the study;\n8. Participants with a history of significant gastric emptying abnormalities, severe gastrointestinal disorder, or gastrointestinal surgery (excluding polypectomy, appendicectomy, and haemorrhoid operation) who are deemed unsuitable for participation in this study upon the evaluation by the investigator;\n9. Participants who have undergone surgeries that may affect drug absorption, distribution, metabolism, or excretion, and are deemed unsuitable for enrollment by the investigator;\n10. Participants who are prone to allergic reactions or with allergic constitution (e.g., those allergic to pollen, two or more drugs\u002Ffoods), or participants with known hypersensitivity to any component of the investigational product or similar drugs (Tirzepatide, GLP-1R agonists, or compounds containing GLP-1R agonists); or participants with a history of photosensitivity.\n11. Blood donation and\u002For blood loss ≥400 mL or bone marrow donation within 3 months prior to screening; or haemoglobinopathy, haemolytic anaemia, or sickle cell anaemia at screening;\n12. Past medical history of moderate to severe depression; or history of suicidal ideation or suicidal behavior; or past medical history of serious psychiatric disorders, e.g., schizophrenia, bipolar affective disorder, etc.; or a score of ≥9 on the Patient Health Questionnaire-9 (PHQ-9) at screening (self-rated by the participant);\n\n    Participants who received any of the following drugs or treatments prior to screening:\n13. Participants who have been previously treated with similar drugs of HS-20094 (Tirzepatide, GLP-1 analogues, or related compounds), and\u002For those who require the use of DPP-4 inhibitors (drugs affecting GLP-1 levels) during the study;\n14. Any use of drugs or treatments that may cause significant weight gain or loss within 3 months prior to screening:\n\n    ① Use of any GLP-1R-related single\u002Fmulti-target drug that promotes weight loss, including, but not limited to, GLP-1R agonists, glucagon-like peptide-1 receptor\u002Fglucagon receptor (GLP-1R\u002FGCGR) agonists, glucagon-like peptide-1 receptor\u002Fglucose-dependent insulinotropic polypeptide receptor (GLP-1R\u002FGIPR) agonists, GLP-1R\u002FGIPR\u002FGCGR agonists, etc.;\n\n    ② Any drug that may cause weight gain, including: systemic glucocorticoid medications (except for short-term use of \\\u003C14 days or topical administration, inhalation, intraocular, or nasal administration), tricyclic antidepressants, atypical antipsychotics, and mood stabilizers (e.g., imipramine, amitriptyline, mirtazapine, paroxetine, phenelzine, chlorpromazine, thioridazine, clozapine, olanzapine, valproate, valproate derivatives, lithium salts), etc.;\n\n    ③ Any Chinese herbal medicines, health care products, meal replacements, weight-reducing teas, etc. or similar products for the purpose of weight loss;\n\n    ④ Any approved or unapproved weight-reducing drugs, such as sibutramine hydrochloride, orlistat, phentermine, phenylpropanolamine, mazindol, phentermine, diethylpropion, lorcaserin, phentermine\u002Ftopiramate coformulation, naltrexone\u002Fbupropion coformulation, etc.;\n\n    ⑤ Any glucose-lowering drugs, such as metformin, sodium-glucose cotransporter-2 (SGLT2) inhibitors, thiazolidinediones (TZDs), etc.;\n15. History of bariatric\u002Fmetabolic surgery within 12 months prior to screening, or participants who have not recovered from any surgery or trauma at screening, or participants who have recovered from gastrointestinal surgery prior to screening that affected gastrointestinal motility;\n16. Participants who have received immunization of any vaccine within four weeks prior to the first dose of the investigational product, or who plan to receive immunization of any vaccine during the study or within 2 weeks after study completion.\n17. Participants who have participated in any other clinical studies and received administration of investigational products within 3 months prior to screening; or the time interval from administration in the previous clinical study is less than 7 half-lives (whichever is longer);\n\n    Participants with any of the following conditions:\n18. Participants with abnormal findings in physical examination, vital signs, clinical laboratory tests, abdominal ultrasound, thyroid color Doppler ultrasound, etc., deemed by the investigator to be clinically significant and assessed as unsuitable for enrollment.\n19. Participants with heart rate (HR) of \\\u003C50 beats per minute or \\>100 beats per minute by 12-lead electrocardiogram (ECG) during screening. A retest is allowed, and the participant will be excluded if both tests fail;\n20. Presence of any of the following abnormalities on 12-lead ECG at screening: second or third degree AV block, long QT syndrome, pre-excitation syndrome, ventricular tachycardia, atrial fibrillation, or QTcF \\>450 ms in males and \\>470 ms in females, or any other arrhythmia deemed clinically significant by the investigator. Participants with abnormal QTcF on the first examination should repeat the ECG twice more, and the mean of the three results should be used as the basis for judgment;\n21. History of drug abuse, drug dependence, or illicit drug use within 5 years prior to screening, or positive urine drug screening;\n22. Participants who consumed excessive amounts of tea, coffee, and\u002For caffeinated beverages (more than 8 cups per day on average, 1 cup = 200 mL) within 3 months prior to screening;\n23. Participants who smoke an average of more than 5 cigarettes per day within the 3 months prior to screening;\n24. Participants who frequently consume alcohol within 3 months prior to screening (i.e., weekly alcohol intake exceeding 14 units, where 1 unit = 14 g of alcohol, equivalent to 360 mL of beer, 45 mL of spirits with alcohol content of 40%, or 150 mL of wine, corresponding to 10 bottles of beer, 500 g of Baijiu, or 3 bottles of red wine per week);\n25. Planned bariatric surgery, acupuncture for weight loss, liposuction, or abdominoplasty during the study; or other planned surgery during the study (except for minor surgery that, in the opinion of the investigator, does not interfere with the study);\n26. Female participants who are in the lactation period within 1 month prior to screening or during the study; or female participants with positive result in pregnancy test;\n27. Participants who have engaged in unprotected sexual intercourse within 14 days prior to study treatment (applicable to female participants only);\n28. Participants with history of needle phobia or blood phobia, or participants assessed by the investigator as having difficulty in blood collection, or participants cannot tolerate blood collection via venipuncture\u002Findwelling needle;\n29. Other participants deemed unsuitable for participating in the study by the investigator or participants who voluntarily withdraw from the study or who are lost to follow-up for personal reasons.",{"count":466,"type":22},144,[59],"This is a multicenter, randomized, open-label, parallel clinical study to evaluate the bioequivalence of the HS-20094 MDV pen and AI pen in overweight or obese subjects.",[470],"Overweight or Obesity","2025-07-09",{"date":454,"type":39},{"date":474,"type":39},"2025-04-16",{"date":89,"type":22},{"name":45,"class":46},{"id":478,"slug":479,"hasResults":12,"nctId":480,"briefTitle":481,"officialTitle":482,"acronym":4,"eligibilityCriteria":483,"healthyVolunteers":54,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":484,"targetDuration":4,"studyType":23,"phases":486,"briefSummary":487,"conditions":488,"keywords":489,"overallStatus":229,"whyStopped":4,"lastUpdateSubmitDate":491,"lastUpdatePostDateStruct":492,"startDateStruct":494,"completionDateStruct":496,"leadSponsor":497,"locationsCount":73},"100596022","phase-1-hs-10542-study-in-healthy-participants-100596022","NCT07040046","HS-10542 Study in Healthy Participants","A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and the Food Effect on the Pharmacokinetics of HS-10542 in Healthy Participants","Inclusion Criteria：\n\n1. Male or female between 18 and 64 years of age (critical values inclusive) when signing the informed consent form.\n2. Body mass index (BMI = weight\u002Fheight2) ≥ 19 kg\u002Fm2 and ≤ 28 kg\u002Fm2 at screening, and body weight ≥ 50 kg for men and ≥ 45 kg for women.\n3. Physical examination, laboratory tests, 12-lead ECG, abdominal B-ultrasound and anteroposterior and lateral chest X-ray (or CT) examination showed no abnormality, or slight abnormality but with no clinical significance as judged by the investigator, or slight abnormality but with controllable risk as judged by the investigator, and communication with the sponsor 's medical and pharmacological personnel is required when necessary;\n4. Female participants are required to agree to practice highly effective contraception from 2 weeks before screening until 60 days after the last dose:\n5. Male participants of childbearing potential are required to agree to practice highly effective contraception from the date of signing the informed consent until 120 days after the last dose; male participants of non-childbearing potential (e.g, having undergone effective sterilization) are required to agree to use additional highly effective contraception in the event of uncertainty about the presence of sperm.\n6. Participants should be able to complete vaccinations against Neisseria meningitidis (types A, C, Y, and W-135) and streptococcus pneumoniae at least 2 weeks prior to the first dose, and if participants have previously received the above vaccines, antibody titers or vaccine manufacturer information should be provided, and booster vaccinations should be completed as needed according to local practice guidelines in the opinion of the investigator to obtain adequate protection during the trial.\n7. The participants are able to communicate clearly with the investigator, understand and comply with the requirements of this trial, have a comprehensive understanding of the study content, process and possible adverse reactions, and sign the informed consent forms voluntarily.\n\nExclusion Criteria:\n\n1. Consumed any caffeinated, tea, alcohol, xanthine-rich foods or beverages within 24 hours before administration.\n2. Consumed foods known to alter hepatic enzyme activity (eg, pitaya, grapefruit, Seville oranges, etc) and their juice drinks within 1 week before administration.\n3. Abnormal vital signs, physical examination, laboratory tests, 12-lead ECG, chest anteroposterior X-ray\u002FCT examination, abdominal ultrasonography, etc. at the time of screening are clinically significant and, as assessed by the investigator, may increase the risk for the participant or affect the interpretation of the study results, which include but are not limited to:\n\n   1. Abnormal liver function: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or total bilirubin (TBiL) ≥ 1.5 times ULN.\n   2. Abnormal renal function: eGFR \\\u003C 60 mL\u002Fmin\u002F1.73 m2 at screening or abnormal renal function as judged by the investigator, calculated using the estimation formula of Chronic Kidney Disease Epidemiology Collaboration 2021 (CKD-EPI): eGFR (mL\u002Fmin\u002F1.73 m2) .\n   3. Abnormal ECG: The absolute value of QTcF (QT interval corrected by Fridericia 's formula \\[QT\u002FRR0.33\\]) \\> 450 msec for males and \\> 470 msec for females; or other clinically significant abnormalities as judged by the investigator.\n4. Positive hepatitis B virus surface antigen (HBsAg), or negative HBsAg but positive hepatitis B core antibody (HBcAb), or positive HCV Ab, or positive result of any test for HIV antibody or Treponema pallidum-specific antibody at screening and is assessed by the investigator as inappropriate to participate in this trial.\n5. participants with inactive, active or latent tuberculosis infection (indicated by tuberculosis on chest X-ray or CT, or positive T-SPOT.TB result) at screening who are assessed as inappropriate for participation in this trial by the investigator.\n6. Women with a positive blood pregnancy test result at screening, breastfeeding women, or participants planning to become pregnant during the trial.\n7. Used any systemic medication or food (e.g, prescription drugs, over-the-counter drugs, Chinese herbal medicines, health products, special medical supplies, formulas, etc) that could affect the metabolism of investigational drug during the washout period or 5 half-lives (whichever is longer) of a particular drug prior to screening, or participants who are unwilling to undergo washout and discontinue such medication throughout the trial and are assessed as inappropriate for participation in this trial by the investigator. Washout periods for systemic medications or food are detailed in Section 6.7.\n8. Those who have been vaccinated with vaccines other than those specified in this protocol within 1 month before screening or are scheduled to be vaccinated within 1 month after the end of the administration.\n9. Those who have participated in a clinical trial involving an intervention with another drug or medical device and received an investigational product or use of a medical device within 1 month prior to screening or within 7 half-lives of the other investigational product, whichever is longer.\n10. Those who have donated blood or lost blood ≥ 450 mL within 3 months prior to screening, or planning to donate blood during the trial and at the end or within 3 months of the trial.\n11. Those who have a known history of smoking (\\> 5 cigarettes per day on average) within 3 months prior to screening.\n12. Those with diseases or medical conditions that may affect the absorption, distribution, metabolism and excretion of oral drugs within 3 months before screening, such as inflammatory bowel disease, peptic ulcer, gastroesophageal reflux disease, chronic diarrhea, subtotal gastrectomy, etc.\n13. Those who have a known history of drug abuse\u002Fabuse within 6 months prior to screening, or test positive for drug abuse at screening.\n14. Those who have a known history of alcohol dependence (an average of ≥ 14 units of alcohol per week, each unit being equivalent to 285 mL of beer, 125 mL of wine, or 25 mL of liquor) within 6 months prior to screening, or a positive breath alcohol test at screening.\n15. Those who have undergone ≥ Grade 2 surgery within 6 months before screening, or plan to have surgery or be hospitalized during the trial.\n16. Those who have a previous history of severe drug, food or environmental allergy, or known hypersensitivity to the active substance and excipients of the investigational product (including HS-10542 and placebo).\n17. Those with a previous history of capsular microorganisms (e.g., meningococcus or pneumococcus) infection, or those with a history of close contact with individuals infected with meningococcal.\n18. Those who have difficulty in swallowing solid preparations such as tablets and capsules.\n19. Participants who have difficulty in blood collection, and cannot tolerate multiple venous blood draws or have any contraindications to blood collection.\n20. Participants with special dietary requirements or inability to comply with the dietary requirements of the study site.\n21. As judged by the investigator, those have a history of or currently have any diseases or conditions that may increase the risk of their participation in the trial, affect their compliance with the protocol, or affect their completion of the trial. These include, but are not limited to, diseases or conditions related to the respiratory, circulatory, digestive, urinary, hematological, endocrine, metabolic, nervous, mental, and immune systems.",{"count":485,"type":22},100,[59],"This is a randomized, double-blind, placebo-controlled, dose escalation phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, and the food effect on the pharmacokinetics of HS-10542 in healthy participants.",[62],[226,490,62],"phase 1","2025-06-18",{"date":493,"type":39},"2025-06-26",{"date":495,"type":39},"2025-05-16",{"date":255,"type":22},{"name":45,"class":46},{"id":499,"slug":500,"hasResults":12,"nctId":501,"briefTitle":502,"officialTitle":503,"acronym":504,"eligibilityCriteria":505,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":506,"targetDuration":4,"studyType":23,"phases":508,"briefSummary":509,"conditions":510,"keywords":517,"overallStatus":229,"whyStopped":4,"lastUpdateSubmitDate":491,"lastUpdatePostDateStruct":523,"startDateStruct":525,"completionDateStruct":527,"leadSponsor":529,"locationsCount":73},"100575218","phase-1-hs-10502-combination-treatment-in-patients-with-advanced-solid-tumors-100575218","NCT06769425","HS-10502 Combination Treatment in Patients With Advanced Solid Tumors","A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HS-10502 Combination Treatment in Subjects With Advanced Solid Tumors","HS-10502","Inclusion Criteria:\n\n* Males or females aged 18 years or older (≥18 years).\n* Patients diagnosed with pathologically confirmed advanced solid tumors.\n* Subjects have at least one target lesion as assessed per the RECIST 1.1.\n* Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 1 and no deterioration within 2 weeks before the first dose.\n* Have a life expectancy of at least 12 weeks.\n* Female subjects of childbearing potential are willing to take appropriate contraceptive measures and should not breastfeed from signing the informed consent until 6 months after the last dose; male subjects must agree to use barrier contraception (i.e. condoms) from signing the informed consent to 6 months after the last dose.\n* Female subjects must have a negative pregnancy test within 7 days prior to the first dose (for subjects with tumor related abnormal elevation of human chorionic gonadotropin \\[HCG\\], an ultrasound of uterus and appendages should be performed within 7 days prior to the first dose to rule out pregnancy), or demonstrate no risk for pregnancy.\n* Subject must be voluntarily enrolled in this clinical trial, be able to understand the study procedures and to sign written informed consent.\n\nExclusion Criteria:\n\n* Have received or is currently receiving the following treatment: PARPi\u002FB7-H4\u002FB7-H3-targeted therapies;\n* Have received or is currently receiving the following treatment: PARPi\u002FB7-H4\u002FB7-H3-targeted therapies;\n* Have received any of cytotoxic chemotherapy drugs, investigational drugs, anti-tumor traditional Chinese medicines or other anti-tumor drugs within 14 days prior to the first dose of study drug; or need to continue these drugs during the study.\n* Presence of Grade ≥ 2 toxicities as per Common Terminology Criteria for Adverse Events due to prior anti-tumor therapy.\n* Presence of pleural\u002Fabdominal effusion requiring clinical intervention.\n* Known history of other primary malignancy.\n* Evidence of brain metastasis and\u002For cancerous meningitis\n* Inadequate bone marrow reserve or hepatic\u002Frenal functions.\n* Cardiological examination abnormality.\n* Severe, uncontrolled or active cardiovascular disorders.\n* Serious or poorly controlled diabetes.\n* Serious or poorly controlled hypertension.\n* Clinically significant bleeding symptoms or significant bleeding tendency within 1 month prior to the first dose of study treatment.\n* Serious infections within 4 weeks prior to the first dose.\n* Have received systemic glucocorticoid therapy for more than 7 days within 28 days prior to the first dose study treatment, or require chronic (≥ 7 days) use of systemic glucocorticoids during the study, or have other acquired, congenital immunodeficiency disorders, or a history of organ transplantation.\n* Presence of active infectious diseases such as hepatitis B, hepatitis C, tuberculosis, syphilis, or human immunodeficiency virus infection, etc.\n* Current hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh Class B or more severe cirrhosis.\n* Any moderate or severe lung diseases that may interfere with the detection and treatment of drug-related pulmonary toxicity or may seriously affect respiratory function.\n* History of severe neurological or psychiatric disorder.\n* Pregnant or breast-feeding women or women who intend to become pregnant during the study.\n* Attenuated live vaccination within 4 weeks prior to the first dose.\n* Subjects with autoimmune disease that is active or is likely to recur.\n* Subjects with gastrointestinal fistula, visceral fistula, gastrointestinal perforation, or abdominal abscess, or with symptoms\u002Fsigns of intestinal obstruction within 6 months prior to the first dose of study drug.\n* Subjects unlikely to comply with study procedures, restrictions and requirement as determined by the investigator.\n* Subjects with any condition that jeopardizes the safety of the patient or interferes with the assessment of the study, as judged by the investigator.",{"count":507,"type":22},157,[59],"HS-10502 is a PARP1-specific selective inhibitor. The purpose if this study is to assess the safety, tolerability, pharmacokinetics (PK), and efficacy of HS-10502 Combination Treatment in subjects with advanced solid tumors.",[511,512,513,514,515,516],"Recurrent Ovarian Cancer","HER2-negative","Advanced Breast Cancer","TNBC","Advanced Prostate Cancer","Advanced Gastric Cancer",[518,504,519,520,514,521,522],"Poly(ADP-ribose) polymerase-1 inhibitor","ovarian cancer","breast cancer","prostate cancer","gastric cancer",{"date":524,"type":39},"2025-06-24",{"date":526,"type":39},"2025-05-07",{"date":528,"type":22},"2026-08-31",{"name":45,"class":46},{"id":531,"slug":532,"hasResults":12,"nctId":533,"briefTitle":534,"officialTitle":535,"acronym":4,"eligibilityCriteria":536,"healthyVolunteers":54,"sex":17,"minAge":18,"maxAge":55,"enrollmentInfo":537,"targetDuration":4,"studyType":23,"phases":539,"briefSummary":540,"conditions":541,"keywords":542,"overallStatus":229,"whyStopped":4,"lastUpdateSubmitDate":544,"lastUpdatePostDateStruct":545,"startDateStruct":546,"completionDateStruct":547,"leadSponsor":549,"locationsCount":73},"100595498","phase-1-evaluate-the-safety-and-pharmacokineticspharmacodynamics-and-food-effect-of-hs-20118-100595498","NCT07033234","Evaluate the Safety and Pharmacokinetics\u002FPharmacodynamics and Food Effect of HS-20118","A Phase I Clinical Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Oral Doses of HS-20118, and the Food Effect (FE) on the Pharmacokinetics in Adult Participants","Inclusion Criteria:\n\nFor the SAD study:\n\n1. Healthy adults aged 18-45 years (inclusive) at the time of signing the informed consent form;\n2. Male participants weighing ≥ 50 kg and female participants weighing ≥ 45 kg, both ≤ 110 kg; body mass index (weight\u002Fsquare of height (kg\u002Fm2)) within the range of 18-28 kg\u002Fm2 (inclusive);\n3. Normal results or abnormal results but without clinical significance in comprehensive examinations, including general physical examination, vital signs, laboratory tests, 12-lead ECG, abdominal color Doppler ultrasound, and chest X-ray from the frontal and lateral position ;\n\nFor the MAD study:\n\n1. Male or female participants aged 18-65 years (inclusive) at the time of signing the informed consent form;\n2. Male participants weighing ≥ 50 kg and female participants weighing ≥ 45 kg, both ≤ 110 kg;\n3. Chronic plaque psoriasis for at least 6 months with or without psoriatic arthritis;\n\nExclusion Criteria:\n\nFor the SAD study:\n\n1. Participants with immune-related diseases and medical history at screening;\n2. Participants with a history of drug or other allergies who are considered by the investigator to be at high risk for participating in this study, or who may be allergic to the investigational medicinal product or any component of the investigational medicinal product as judged by the investigator;\n3. History of drug abuse within the past 5 years or use of illicit drugs within 3 months before the study; or positive for urine drug screening;\n\nFor the MAD study:\n\n1. Guttate psoriasis, pustular psoriasis, erythrodermic psoriasis, drug-induced psoriasis, or other diseases that affect the treatment results;\n2. Current use of prohibited drugs or prior use of prohibited drugs within the specific time periods;\n3. Known history of recurrent or chronic infections, or prior history of chronic or recurrent infections, including but not limited to: chronic renal infection, chronic chest infection (e.g., bronchiectasis), symptomatic urinary tract infection, and open, draining, or infected skin wounds; history of serious infections (e.g., sepsis, pneumonia, and pyelonephritis), or hospitalization or treatment with intravenous antibiotics for infections within 2 months before screening;",{"count":538,"type":22},142,[59],"The study will be conducted in 2 parts (SAD and FE for Part 1 and MAD for Part2).\n\nPart 1 is a single-center, randomized, double-blind, placebo-controlled, SAD study to evaluate the safety, tolerability, immunogenicity, and PK of HS-20118 and explore the food effect and fasting time on PK after a single oral dose in healthy participants.\n\nPart 2 is a multi-center, randomized, double-blind, placebo-controlled, MAD study to evaluate the safety, tolerability, immunogenicity, PK, and PD of HS-20118 after multiple oral doses in patients with moderate to severe plaque psoriasis.",[426],[543],"psoriasis","2025-06-13",{"date":524,"type":39},{"date":495,"type":39},{"date":548,"type":22},"2026-03",{"name":45,"class":46},{"id":551,"slug":552,"hasResults":12,"nctId":553,"briefTitle":554,"officialTitle":555,"acronym":4,"eligibilityCriteria":556,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":145,"enrollmentInfo":557,"targetDuration":4,"studyType":23,"phases":559,"briefSummary":560,"conditions":561,"keywords":567,"overallStatus":229,"whyStopped":4,"lastUpdateSubmitDate":569,"lastUpdatePostDateStruct":570,"startDateStruct":572,"completionDateStruct":574,"leadSponsor":576,"locationsCount":73},"100496186","phase-1-a-study-of-hansoh-hs-10502-in-patients-with-advanced-solid-tumors-100496186","NCT05740956","A Study of Hansoh (HS)-10502 in Patients With Advanced Solid Tumors","A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HS-10502 in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Males or females aged 18 - 75 years (inclusive).\n2. Having at least one target lesion per the RECIST v1.1.\n3. For the phase Ia Cohort A: advanced solid tumor carrying HRR gene mutation with failure or intolerance or not available to the currently available Standard of care (SoC).\n4. For the phase Ib study:\n\n   Cohort B: patients with HRD positive recurrent ovarian cancer with failure or intolerance or not available to SoC Cohort C: patients with HRR gene mutation advanced Human epidermal growth factor receptor 2 (HER2)-negative breast cancer with failure or intolerance or not available to SoC Cohort D: patients with HRR gene mutation advanced pancreatic cancer with failure or intolerance or not available to SoC Cohort E: patients with HRR gene mutation mCRPC with failure or intolerance or not available to SoC Cohort F: patients with HRR gene mutation colorectal cancer with failure or intolerance or not available to SoC Cohort G: patients with other HRR gene mutation or HRD positive advanced solid tumors with failure or intolerance or not available to SoC\n5. Eastern cooperative oncology group (ECOG) performance status was 0-1.\n6. Minimum life expectancy \\> 12 weeks.\n7. Females should be using adequate contraceptive measures and should not be breastfeeding Males should be using adequate contraceptive measures.\n8. Have signed Informed Consent Form.\n\nExclusion Criteria:\n\n1. Received or are receiving the following treatments:\n\n   1. Previous or current treatment with two or more Poly(ADP-ribose) polymerase (PARP) inhibitors.\n   2. Traditional Chinese medicine indicated for tumors within 2 weeks prior to the first dose of study treatment.\n   3. Cytotoxic chemotherapeutic drugs, investigational drugs or other systematic anti-tumor therapies within 3 weeks before the first dose of study treatment; Nitrosourea or Mitomycin C within 6 weeks prior to the first dose of study treatment.\n   4. Local radiotherapy within 2 weeks prior to the first dose of study treatment; more than 30% of bone marrow radiotherapy or large-area irradiation within 4 weeks before the first dose of study treatment.\n   5. Presence of pleural effusion\u002Fascites requiring clinical intervention; presence of pericardial effusion.\n   6. Major surgery within 4 weeks prior to the first dose of study treatment.\n2. Presence of Grade ≥ 2 toxicities due to prior anti-tumor therapy.\n3. History of other primary malignancies.\n4. Known and untreated, or active central nervous system metastases.\n5. Inadequate bone marrow reserve or hepatic and renal functions.\n6. Myelodysplastic syndromes (MDS) or acute myeloid leukemia (AML), or with features suggestive of MDS or AML.\n7. Severe, uncontrolled or active cardiovascular disorders.\n8. Diabetic ketoacidosis or hyperosmolar hyperglycemic state within 6 months prior to the first dose of study treatment; glycosylated hemoglobin ≥ 7.5%.\n9. Serious or poorly controlled hypertension.\n10. Any life-threatening hemorrhagic event or events requiring blood transfusion within 120 days prior to the first dose of study treatment. Clinically significant hemorrhagic symptoms or obvious hemorrhagic tendency.\n11. Serious infection within 4 weeks prior to the first dose of study treatment, or presence of uncontrollable active infection in the screening period.\n12. Having serious neurological or mental disorders.\n13. A history of hypersensitivity to any of the active or inactive ingredients of HS-10502 or drugs with a similar chemical structure to HS-10502 or in the same class as HS-10502.\n14. Patients who may have poor compliance with the procedures and requirements of the study, as judged by the investigator.\n15. Patients with any condition that jeopardizes the safety of the patient or interferes with the assessment of the study, as judged by the investigator.",{"count":558,"type":22},318,[59],"HS-10502 is a Poly(ADP-ribose) polymerase 1 (PARP1)-specific selective inhibitor. The purpose if this study is to assess the safety, tolerability, pharmacokinetics (PK), and efficacy of HS-10502 in subjects with homologous recombination repair (HRR) gene mutant or homologous recombination deficiency (HRD) positive advanced solid tumors.",[562,563,564,565,566],"Ovarian Cancer","Breast Cancer","Pancreatic Cancer","Prostatic Cancer","Colorectal Cancer",[518,504,562,563,568],"Prostate Cancer, Colorectal Cancer","2025-06-02",{"date":571,"type":39},"2025-06-05",{"date":573,"type":39},"2023-06-09",{"date":575,"type":22},"2026-10-01",{"name":45,"class":46},{"id":578,"slug":579,"hasResults":12,"nctId":580,"briefTitle":581,"officialTitle":582,"acronym":4,"eligibilityCriteria":583,"healthyVolunteers":54,"sex":17,"minAge":18,"maxAge":101,"enrollmentInfo":584,"targetDuration":4,"studyType":23,"phases":585,"briefSummary":586,"conditions":587,"keywords":589,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":591,"lastUpdatePostDateStruct":592,"startDateStruct":594,"completionDateStruct":596,"leadSponsor":597,"locationsCount":4},"100593080","phase-1-a-study-to-assess-the-safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-hs-10510-in-healthy-subjects-100593080","NCT07001787","A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HS-10510 in Healthy Subjects","A Phase I, Randomized, Double-Blind, Placebo-controlled Study to Assess the Safety, Tolerability，Pharmacokinetics, and Pharmacodynamics of HS-10510 Following Single and Multiple Ascending Dose Administration to Healthy Subjects With or Without Elevated LDL-C Levels","Inclusion Criteria:\n\n1. Healthy male and female subjects aged 18-55 years (inclusive) at the time of signing the informed consent form.\n2. Agree to use highly effective contraception from the date of signing the informed consent to 30 days after the last dose.\n3. Male or female subjects agree to avoid donating sperm or eggs from the date of signing the informed consent to 90 days after the last dose.\n4. Female subjects of childbearing potential must have a negative blood pregnancy test within 3 days before dosing.\n5. Based on the medical history, physical examination, vital signs (VS) measurements, and ECG and safety test results conducted during the screening visit and before randomization, the subject is in good health.\n6. The subject has a full understanding of the trial content, process, and potential adverse reactions, is willing to strictly adhere to the trial protocol to complete this study, and voluntarily signs the informed consent form.\n7. No more than 14 units of alcohol (1 unit = 285 mL of beer, 25 mL of spirits, 125 mL of wine) in a single session within two weeks before screening; no alcohol (including alcohol-containing products) 48 hours before dosing and throughout the study period.\n8. No smoking 48 hours before dosing and throughout the study period.\n9. No more than 6 cups (approximately 250 mL per cup) of coffee, tea, cola, or other caffeine-containing beverages on average per day within three months before screening; no xanthine- or caffeine-containing foods or beverages throughout the study period.\n10. Maintain a stable diet and exercise lifestyle throughout the study period; avoid all activities that may cause injury or intense physical activity.\n11. Agree to avoid consuming grapefruit, grapefruit juice, bitter orange, bitter orange juice, or other products containing grapefruit or bitter orange, mulberry juice, cruciferous vegetables (such as kale, watercress, Chinese broccoli, Brussels sprouts, and mustard greens), or grilled meats from 7 days before dosing to the end of the last visit.\n\n    For Part A\n12. BMI between 19.0-28.0 kg\u002Fm2 (inclusive), with a minimum weight of 50.0 kg for males and 45.0 kg for females.\n\n    For Part B\n13. Fasting LDL-C between 1.8-4.9 mmol\u002FL (inclusive) at screening.\n14. Fasting triglycerides ≤4.52 mmol\u002FL at screening.\n15. BMI between 20.0-35.0 kg\u002Fm2 (inclusive), with a minimum weight of 50.0 kg for males and 45.0 kg for females.\n\n    For Part C\n16. Fasting LDL-C between 2.6-4.9 mmol\u002FL (inclusive) at screening.\n17. Fasting triglycerides ≤4.52 mmol\u002FL at screening.\n18. BMI between 20.0-35.0 kg\u002Fm2 (inclusive), with a minimum weight of 50.0 kg for males and 45.0 kg for females.\n19. LDL-C reduction of ≥30% after a 28-day rosuvastatin run-in period.\n\nExclusion Criteria:\n\n1. Subjects with clinically significant abnormalities in vital signs, physical examination, or laboratory test results during the screening period, as determined by the investigator (a single retest may be performed within the screening window if there is a clear reason for retesting, and the retest results will be used for screening).\n2. Subjects who have undergone LDL apheresis or plasmapheresis within 12 months before screening.\n3. Subjects who have donated or lost ≥400 mL of blood or received a blood transfusion or bone marrow donation within 3 months before screening; or donated or lost ≥200 mL of blood within 1 month before screening.\n4. Subjects with clinically significant abnormalities in 12-lead ECG results at screening, as determined by the investigator (e.g., QTcF interval (Fridericia's formula) \\>450 msec for males, \\>470 msec for females; PR interval \\>200 msec, etc.).\n5. Subjects with systolic blood pressure ≥140 mmHg and\u002For diastolic blood pressure ≥90 mmHg at screening.\n6. Subjects with alanine aminotransferase (ALT) \\>1.5×ULN, aspartate aminotransferase (AST) \\>1.5×ULN, or total bilirubin (TBIL) \\>1×ULN at screening.\n7. Pregnant or breastfeeding females.\n8. Subjects who have undergone major surgery within 3 months before screening or plan to undergo surgery during the study period.\n9. Subjects who are positive for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), HIV antibody (HIV-Ab), or syphilis serospecific antibody (TP-Ab).\n10. Subjects who are heavy smokers or have smoked an average of 5 or more cigarettes per day within 3 months before screening.\n11. Subjects with difficulty in venous blood collection or who experience fainting or dizziness during blood collection.\n12. Subjects who have taken any medication, including prescription drugs, over-the-counter drugs, herbal medicines, or dietary supplements, within 2 weeks or 5 half-lives (whichever is longer) before screening, and are expected to take any medication during the study period (except for the rosuvastatin treatment in Part C) (excluding treatment for adverse events).\n13. Subjects with diseases or conditions that, as determined by the investigator, could significantly affect the absorption of drugs or nutrients, such as clinically significant gastrointestinal diseases (e.g., active inflammatory bowel disease) or symptoms of gastrointestinal disorders; or any condition that could affect drug absorption, such as subtotal or total gastrectomy, gastric bypass, or any bowel resection.\n14. Subjects whom the investigator deems ineligible.\n\n    Subjects with the following diseases or medical history before screening or before randomization:\n15. Subjects with a history of severe allergy\u002Fhypersensitivity or ongoing clinically significant allergy\u002Fhypersensitivity, or a history of hypersensitivity to drugs with a chemical structure similar to HS-10510, as determined by the investigator.\n16. Subjects with a history of endocrine diseases that could significantly affect body weight, such as diabetes, Cushing's syndrome, hypothyroidism, or hyperthyroidism.\n17. Subjects with a history of moderate to severe depression or a history of severe psychiatric disorders, such as schizophrenia or bipolar disorder.\n18. Subjects with a history of acute or chronic hepatitis or other severe liver diseases, except for non-alcoholic fatty liver disease.\n19. Subjects with a history of severe cardiovascular disease within 6 months before screening, including decompensated heart failure (NYHA class III and IV), unstable angina, stroke or transient ischemic attack, acute myocardial infarction, severe arrhythmia, or coronary artery bypass grafting or percutaneous coronary intervention.\n20. Subjects with a history of or current severe infection, such as cellulitis, pneumonia, or sepsis, within 30 days before screening.\n21. Subjects with a history of drug abuse or illicit drug use within 1 year before screening, or positive results on urine drug screening.\n22. Subjects with a history of alcoholism or who have consumed more than 14 units of alcohol (1 unit = 285 mL of beer, 25 mL of spirits (≥35% alcohol), 150 mL of wine) in a single session within 2 weeks before screening, or positive results on alcohol breath testing at screening.\n23. Subjects with a history of malignant tumors.\n24. Subjects who have received or plan to receive live (attenuated) vaccines within 12 weeks before screening.\n25. Subjects with concurrent cardiovascular, liver, kidney, gastrointestinal, psychiatric, neurological, hematological, or metabolic disorders.\n\n    Subjects who have used any of the following medications or treatments before screening:\n26. Subjects who have used medications that could affect cholesterol levels (e.g., statins, ezetimibe, niacin, and supplements such as ω-3 fatty acids) within 8 weeks before screening.\n27. Subjects who are currently or have previously received inclisiran sodium or other investigational siRNA PCSK9 inhibitors.\n28. Subjects who have received PCSK9 inhibition (approved or investigational) treatment within 12 months before screening.\n29. Subjects who have received microsomal triglyceride transfer protein inhibitors (e.g., lomitapide) within 12 months before screening.\n30. Subjects who have received systemic steroid therapy, immunomodulatory therapy, or chemotherapy within 3 months before screening, or who may receive these treatments during the study period.\n31. Subjects who are currently receiving or have received medications known to prolong the QT interval (refer to the package insert) within 14 days before screening.\n\n    Subjects with any of the following conditions:\n32. Subjects who have participated in any drug or medical device clinical trial and received at least one treatment (including placebo) within 12 weeks before screening, or are still within 5 half-lives of the investigational drug (whichever is longer, excluding those who did not receive the investigational drug or device).\n33. Subjects who are strict vegetarians or have medical dietary restrictions.",{"count":103,"type":22},[59],"This study will assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of HS-10510 following single and multiple dose administration to healthy subjects with or without elevated Low-Density Lipoprotein-Cholesterol (LDL-C) levels.\n\nThis study will consist of three parts (Parts A，B and C). 32 subjects have been planned for Part A and up to 36 subjects for Part B and 20 subjects for Part C.",[588],"Dyslipidemia",[590],"Elevated LDL-C；Hypercholesterolemia","2025-05-23",{"date":593,"type":39},"2025-06-03",{"date":595,"type":22},"2025-06",{"date":548,"type":22},{"name":45,"class":46},""]