[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Haisco Pharmaceutical Group Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":547},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,40,0,25,[9,43,66,92,112,132,153,173,195,215,234,256,277,295,315,334,356,376,398,417,439,460,481,506,527],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100053709","phase-1-hsk41959-with-standard-therapy-in-solid-tumors-with-mtap-deletion-100053709",false,"NCT07699757","HSK41959 With Standard Therapy in Solid Tumors With MTAP Deletion","Phase Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HSK41959 Tablets in Combination With Standard Therapy in Patients With MTAP Deletion Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n1. Adult participants aged 18 years or older.\n2. ECOG performance status of 0 to 1.\n3. Life expectancy of at least 3 months.\n4. Histologically or cytologically confirmed advanced malignant tumor with MTAP deficiency identified by a validated assay.\n5. At least one measurable lesion according to RECIST version 1.1.\n6. For NSCLC cohorts: advanced or metastatic NSCLC meeting protocol-specified disease characteristics and prior treatment requirements.\n7. For PDAC cohorts: advanced or metastatic PDAC meeting protocol-specified disease characteristics and prior treatment requirements.\n8. Adequate bone marrow, hepatic, renal, and coagulation function.\n9. Willingness to provide tumor tissue and\u002For undergo protocol-required biomarker testing, if applicable.\n\nExclusion Criteria:\n\n1. Prior exposure to agents targeting the MAT2A or PRMT5 pathway.\n2. Prior antitumor therapy or unresolved toxicities not meeting protocol-defined washout\u002Frecovery requirements.\n3. Known actionable driver alterations or prior therapies excluded by the protocol for specific NSCLC cohorts (for example EGFR, ALK, ROS1, BRAF, NTRK, MET, RET, KRAS G12C, HER2, as applicable).\n4. Significant gastrointestinal disorders that may affect drug absorption.\n5. Clinically significant cardiovascular disease, including clinically relevant QTc prolongation, reduced left ventricular ejection fraction, or severe heart failure.\n6. Uncontrolled metabolic disease, uncontrolled hypertension, or active infection.\n7. Known HIV infection, active hepatitis B with significant viral replication, or active hepatitis C infection.\n8. Use of prohibited concomitant medications, including strong inhibitors or inducers of CYP3A4, P-gp, BCRP, or other protocol-specified transporters\u002Fenzymes within the required washout period.\n9. Other serious medical or psychiatric conditions that, in the investigator's judgment, would make study participation inappropriate.","ALL","18 Years",{"count":20,"type":21},258,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This is a Phase Ib, open-label, multicenter study of HSK41959 tablets in combination with standard therapy in patients with MTAP-deficient advanced solid tumors. The study consists of dose-escalation and dose-expansion parts and is intended to evaluate the safety, tolerability, dose-limiting toxicity, maximum tolerated dose, pharmacokinetics, pharmacodynamics, and preliminary efficacy of HSK41959 tablets when used together with standard therapy.",[27,28,29],"Non-Small Cell Lung Cancer","Pancreatic Ductal Adenocarcinoma (mPDAC)","Advanced Solid Tumors","NOT_YET_RECRUITING","2026-07-07",{"date":33,"type":34},"2026-07-13","ACTUAL",{"date":36,"type":21},"2026-07",{"date":38,"type":21},"2029-11",{"name":40,"class":41},"Haisco Pharmaceutical Group Co., Ltd.","INDUSTRY",1,{"id":44,"slug":45,"hasResults":12,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":50,"sex":17,"minAge":18,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":42},"100640876","phase-1-first-in-human-study-of-hsk56630-in-healthy-subjects-100640876","NCT07580794","First-in-human Study of HSK56630 in Healthy Subjects","A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HSK56630 in Healthy Participants","Inclusion Criteria:\n\n1. Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the study, including possible risks and adverse effects.\n2. Adult males and females between ≥ 18 and ≤ 60 years (inclusive) at Screening.\n3. Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kg\u002Fm2 with a body weight ≥ 50 kg (males) or ≥45 kg (females) at Screening.\n4. Participants with normal results or non-clinically significant (NCS) abnormal results in the opinion of the PI or delegate for a comprehensive examination, including physical examination, vital signs examination, laboratory tests (hematology, biochemistry, coagulation and urinalysis), chest X-ray and abdominal ultrasound.\n5. Female participants are eligible to participate if they are not pregnant, not breastfeeding. Male participants must agree to practice true abstinence; be surgically sterilized (performed at least 6 months prior to screening and documented to no longer produce sperm - verbal confirmation through medical history review acceptable); or agree to use a condom plus effective contraception methods for their female partner.\n6. Able and willing to attend the necessary visits to the study site.\n\nExclusion Criteria:\n\n1. Participants with any clinically significant medical history that may affect the safety evaluation or in vivo process of IP as judged by the PI or delegate, including central nervous, cardiovascular, digestive, respiratory, urinary, blood, immune and endocrine diseases. Participants with childhood asthma (resolved) can be included at the discretion of the PI.\n2. Underlying physical or psychological medical condition that, in the opinion of the PI or delegate, would make the participant unlikely to comply with the protocol or complete the study per protocol.\n3. Participants having special dietary requirements that cannot be accommodated by the unit or that may interfere with study safety or data (e.g. exclusively vegan diet).\n4. Participants who have taken any prescription drugs (excluding contraception) or herbal medicines within 14 days prior to dosing, or have taken any over-the-counter drugs or dietary supplements (including vitamin and calcium supplements) within 7 days prior to dosing; or participants still within 5 half-lives of a drug prior to dosing.\n5. Alkaline phosphatase (ALP), aspartate aminotransferase (AST), and alanine aminotransferase (ALT) \\>1.5 × upper limit of normal (ULN) at Screening or Day -1. Repeat testing at Screening is acceptable for out-of-range values following approval by the PI or delegate.\n6. Participants who have been vaccinated 4 weeks prior to first dose or plan to be vaccinated during the study.\n7. Participants who have taken any other investigational product, participated in any other clinical trial, or participated in other medical research activities within 30 days or 5 half-lives whichever is longer prior to first dose and are unsuitable for participating in this study as judged by the PI or delegate.\n8. Ascertained or presumptive hypersensitivity (including allergies) to any ingredient of the IP; history of other significant allergies or anaphylaxis, as determined by the PI or delegate.\n9. Participants who have lost or donated more than 400 mL of blood (excluding menstrual blood loss in females) within 3 months prior to first dose, or plan to donate blood during the study or within 1 month after the end of the study.\n10. Participants who drink excessive tea, coffee or caffeinated beverages (over 8 cups per day on average, 250 mL per cup) within 6 months prior to Screening, or those who cannot abstain from them on Day -1 and during confinement study in the CRU.\n11. Current smoker who smoke more than 5 cigarettes (or equivalent for other nicotine-containing products) per day within 3 months prior to the first dose, or those who cannot abstain from smoking tobacco or the use of nicotine-containing products during the confinement period.\n12. Participants who regularly drink more than 14 standard units of alcohol per week for females and more than 21 standard units of alcohol per week for males; 1 standard unit contains 10 g of alcohol, such as 285 mL of beer, 30 mL of 40% spirits or 100 mL of wine within 6 months prior to Screening or those who cannot abstain from alcohol on Day -1 and during the confinement study; or those with positive alcohol breath test.\n13. Substance abuse-related disorder or a history of drug, and\u002For substance abuse deemed significant by the PI or delegate at Screening or a positive urine drug screen on Screening or Day -1 (including amphetamine, benzodiazepine, cocaine, methamphetamines, opiates, THC, MDMA, tricyclic antidepressants, barbiturates).\n14. Participants with clinically significant abnormal 12-lead electrocardiogram (ECG) results as judged by the PI or delegate or with a corrected QTc (formula: QTcF = QT\u002FRR1\u002F3) interval ≤ 350 msec or greater than 450 msec in males and 470 msec in females.\n15. Participants with positive test results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), treponema pallidum antibody (Syphilis TP Ab) or human immunodeficiency virus antibody (HIV Ab) at Screening.\n16. Participants with positive result for quantiFERON gold at Screening.\n17. Participants with estimated glomerular filtration rate (eGFR) \\\u003C 90 mL\u002Fmin\u002F1.73m2 (using the CKD-EPI equation).\n18. History or presence of a condition associated with significant immunosuppression.\n19. Exposure to any drugs that cause significant immunosuppression (including experimental therapies as part of a clinical study) within 4 months or 5 half lives (whichever is longer), prior to Screening.\n20. Participants who may not be able to complete the study for other reasons, cannot comply with the requirements of the study, or are unsuitable to participate in the study as judged by the PI or delegate.",true,"60 Years",{"count":5,"type":21},[24],"This is a first-in-human, single ascending dose (SAD) study in healthy adult participants. This is a single-center, randomized, double-blind, placebo-controlled, SAD study to evaluate the safety, tolerability and PK of HSK56630 in healthy adult participants and preliminarily evaluate the PD of HSK56630.",[56],"Healthy Volunteer","RECRUITING","2026-06-21",{"date":60,"type":34},"2026-06-24",{"date":62,"type":34},"2026-06-17",{"date":64,"type":21},"2026-12-31",{"name":40,"class":41},{"id":67,"slug":68,"hasResults":12,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":12,"sex":17,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":4,"studyType":22,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":42},"100641713","phase-3-a-phase-3-clinical-trial-to-evaluate-the-safety-and-efficacy-of-hsk39004-inhalation-suspension-in-patients-with-copd-100641713","NCT07658339","A Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of HSK39004 Inhalation Suspension in Patients With COPD","A Phase III Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Clinical Study to Evaluate the Efficacy and Safety of HSK39004 Inhalation Suspension in the Treatment of Chronic Obstructive Pulmonary Disease (COPD)","Key Inclusion Criteria:\n\n1. Aged 40 to 80 years (inclusive) at the time of screening visit (Visit 1), male or female;\n2. Subjects diagnosed with chronic obstructive pulmonary disease (COPD) in accordance with the GOLD 2026 diagnostic criteria prior to screening \\[GOLD 2026 criteria: presence of chronic respiratory symptoms such as dyspnea, chronic cough or sputum production, and\u002For a history of risk factor exposure, and the pulmonary function test results show: the forced expiratory volume in one second (FEV1) after using bronchodilators \u002F forced vital capacity (FVC) \\\u003C0.7\\];\n3. At screening visit (Visit 1):\n\n   * Post-bronchodilator FEV1\u002FFVC \\\u003C 0.7; and\n   * Post-bronchodilator FEV1 ≥ 30% and \\\u003C 80% of predicted value;\n4. Modified Medical Research Council (mMRC) dyspnea scale score ≥ 2 at screening;\n\nKey Exclusion Criteria:\n\n1. Known hypersensitivity to HSK39004 inhalation suspension, salbutamol, or any component of the drug delivery system;\n2. History of life-threatening acute exacerbation of COPD;\n3. Acute exacerbation of COPD (excluding the use of short-acting bronchodilators alone) or hospitalization for pneumonia within 12 weeks prior to screening (Visit 1);\n4. Acute (viral or bacterial) upper or lower respiratory tract infection within 6 weeks prior to screening (Visit 1);\n5. Diagnosis of any other clinically significant respiratory disease besides COPD, including but not limited to: alpha-1 antitrypsin deficiency, bronchial asthma, active tuberculosis, lung cancer, pulmonary edema, cystic fibrosis, bronchiolitis obliterans, pulmonary sarcoidosis, or clinically significant idiopathic pulmonary fibrosis, pulmonary arterial hypertension, bronchiectasis (except asymptomatic localized bronchiectasis) that, in the opinion of the investigator, poses a safety risk to the participant or may affect the analysis of study result;\n6. Severe or uncontrolled cardiovascular disease or history;\n7. History of malignancy (except for carcinoma in situ, cutaneous squamous cell carcinoma, and basal cell carcinoma cured for more than 5 years), suspected malignancy, or undetermined neoplasm;\n8. Concurrent severe, uncontrolled renal, neurological, endocrine, thyroid, urological, ophthalmic, immunological, psychiatric, gastrointestinal, hepatic, or hematological diseases\u002Fabnormalities that, in the investigator's judgment, may pose a safety risk to the subject or confound study outcome analysis;\n9. History of lung lobectomy or lung volume reduction surgery within 12 months prior to screening;\n10. Subjects determined by the investigator to require oxygen therapy;\n11. Clinically significant sleep apnea requiring continuous positive airway pressure (CPAP) or non-invasive positive pressure ventilation (NIPPV)","40 Years","80 Years",{"count":76,"type":21},387,[78],"PHASE3","The purpose of this study is to evaluate the efficacy and safety of HSK39004 Inhalation Suspension in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD).",[81],"COPD (Chronic Obstructive Pulmonary Disease)",[83],"PDE3\u002F4","2026-06-15",{"date":86,"type":34},"2026-06-22",{"date":88,"type":21},"2026-07-11",{"date":90,"type":21},"2027-06-11",{"name":40,"class":41},{"id":93,"slug":94,"hasResults":12,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":4,"eligibilityCriteria":98,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":99,"targetDuration":4,"studyType":22,"phases":101,"briefSummary":102,"conditions":103,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":106,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":4},"100641831","phase-3-a-phase-3-study-evaluating-the-safety-and-efficacy-of-hsk31679-in-patients-with-mash-100641831","NCT07581951","A Phase 3 Study Evaluating the Safety and Efficacy of HSK31679 in Patients With MASH","A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of HSK31679 in Patients With Metabolic Dysfunction Associated Steatohepatitis (MASH)","Key Inclusion Criteria:\n\n* 1\\. Must be willing to participate in the study and provide written informed consent.\n* 2.Male and female adults ≥ 18 years of age.\n* 3.Have at least one cardiometabolic risk factors at screening.\n* 4.MRI-PDFF fat fraction ≥8%.\n* 5.Have a liver biopsy performed within 6 months prior to randomization, with histologically confirmed MASH assessed by the central laboratory; NAS score ≥ 4 points with at least 1 point each for inflammation and hepatocellular ballooning; meanwhile, CRN fibrosis stage is F2 ≤ fibrosis \\\u003C F4. If no liver biopsy data are available within 6 months prior to randomization, a liver biopsy must be completed during the screening period.\n* 6.Body weight fluctuation \\\u003C 5% for at least 6 weeks before randomization.\n\nKey Exclusion Criteria:\n\n* 1\\. History of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to Screening.\n* 2.MELD score ≥12 due to hepatic disease。\n* 3.Received medication therapy that may induce MAFLD\u002FMASH for ≥ 2 weeks within 12 months prior to liver biopsy (including historical biopsy).\n* 4.Participants who had not been on stable medication with vitamin E (dose\\>400 IU\u002Fday) or polyunsaturated fatty acids or ursodeoxycholic acid within 6 months prior to liver biopsy (including historical biopsy); or had not been on stable medication with thiazolidinediones (TZD), sodium-glucose cotransporter 2 (SGLT2) inhibitors, or complex oral antidiabetic (OAD) regimens (≥3 OADs) within 3 months prior to liver biopsy (including historical biopsy).\n* 5.Participants who have undergone bariatric surgery (e.g., gastroplasty, Roux-en-Y gastric bypass, etc.) within 5 years prior to screening or plan to receive such surgery during the study.\n* 6.HbA1c ≥ 8.0%.\n* 7.Chronic liver diseases other than NASH.\n* 8.Active autoimmune disease. 9.Serum ALT \\> 250 U\u002FL. 10.Active, serious medical disease with a likely life expectancy \\\u003C 2 years.",{"count":100,"type":21},400,[78],"A phase 3, randomized, double-blind, placebo-controlled study evaluating the safety and tolerability of HSK31679 compared to placebo in patients with metabolic dysfunction-associated steatohepatitis (MASH) .",[104,105],"MASH - Metabolic Dysfunction-Associated Steatohepatitis","NASH (Non-Alcoholic Steatohepatitis)",{"date":62,"type":34},{"date":108,"type":21},"2026-06-30",{"date":110,"type":21},"2032-12-30",{"name":40,"class":41},{"id":113,"slug":114,"hasResults":12,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":4,"eligibilityCriteria":118,"healthyVolunteers":12,"sex":17,"minAge":73,"maxAge":74,"enrollmentInfo":119,"targetDuration":4,"studyType":22,"phases":121,"briefSummary":122,"conditions":123,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":42},"100643469","phase-3-a-multicenter-randomized-double-blind-placebo-controlled-parallel-group-phase-iii-study-of-hsk39004-inhalation-powder-for-the-treatment-of-copd-100643469","NCT07583849","A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase III Study of HSK39004 Inhalation Powder for the Treatment of COPD","A Phase III Clinical Study to Evaluate the Efficacy and Safety of HSK39004 Inhalation Powder in the Treatment of Chronic Obstructive Pulmonary Disease (COPD): a Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Design","Inclusion Criteria:\n\n* 1)During the screening visit (Visit 1), the age range is 40 to 80 years (including the threshold value), and gender is not restricted; 2) The body mass index is within the range of 18 to 30 kg\u002Fm2 (including the threshold value); 3) The subjects with chronic obstructive pulmonary disease (COPD) as per the GOLD 2025 diagnostic criteria, and the symptoms before screening were consistent with COPD for at least 1 year \\[GOLD 2025 standard: the subjects have chronic respiratory symptoms such as shortness of breath, chronic cough or expectoration, and\u002For have a history of exposure to risk factors, and the pulmonary function test results show: the forced expiratory volume in one second (FEV1) after using bronchodilators \u002F forced vital capacity (FVC) \\\u003C0.7\\]; 4) During the screening visit (Visit 1):\n\n  * FEV1\u002FFVC after using bronchodilators is \\\u003C0.7;\n  * 30% of the expected value ≤ FEV1 after using bronchodilators \\\u003C 80% of the expected value; Note: Using bronchodilators refers to using 400 μg (4 puffs, 100 μg per puff, with an interval of 1 minute between each puff) salbutamol inhalation aerosol for 15 to 30 minutes after use.\n\n    5\\) At the time of screening, the modified British Medical Research Council (mMRC) dyspnea scale score is ≥ 2; 6）Current smokers with a smoking quantity of ≥ 10 packs per year (smoking index (pack years) = daily smoking quantity (packs) × time (years), 1 pack = 20 cigarettes), or former smokers (for example: at least 1 pack per day, for 10 years), or those with a history of exposure to other risk factors.\n\nExclusion Criteria:\n\n* 1） Lactose\u002Fmilk protein (dairy products) intolerance, allergy to HSK39004 inhalation powder or salbutamol or any known components in the administration system; 2）Have received treatment for COPD acute exacerbation or been hospitalized for pneumonia within 12 weeks before screening; 3) Have had acute (viral or bacterial) upper or lower respiratory tract infections or other infectious diseases requiring antibiotic treatment within 6 weeks before screening; 4) Have other diagnosed respiratory system diseases other than COPD, including but not limited to: α-1 antitrypsin deficiency, asthma, active tuberculosis, lung edema, cystic fibrosis, bronchiectasis, pulmonary nodular disease, or clinically significant pulmonary fibrosis, pulmonary hypertension, interstitial lung disease, bronchiectasis (excluding asymptomatic local bronchial dilation); 5) Have a history of or currently have severe cardiovascular diseases, including but not limited to:\n\n  * Screening period NYHA cardiac function grade III\u002FIV (according to the NYHA cardiac function grading standard, see Appendix 1);\n  * Had acute myocardial infarction, unstable angina pectoris\u002Facute coronary syndrome, percutaneous coronary intervention, coronary artery bypass grafting within 6 months before screening;\n  * Structural heart disease, such as hypertrophic cardiomyopathy, moderate to severe valvular disease;\n  * Had severe arrhythmia within 3 months before screening, such as: atrial fibrillation with a ventricular rate \\> 120 bpm, ventricular tachycardia, bradycardia (ventricular rate \\\u003C 45 bpm), second-degree II or above atrioventricular conduction block (excluding those with implanted pacemaker or defibrillator), male QTcF \\> 450 ms or female QTcF \\> 470 ms;\n  * Subjects with poor blood pressure control (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg at the screening visit); 6) Have type I diabetes or poorly controlled type II diabetes (fasting blood glucose ≥ 10 mmol\u002FL at screening); 7) Have cancer (in situ cancer that has been cured for more than 5 years, skin squamous cell carcinoma and basal cell carcinoma, etc., except for subjects with suspected malignant tumors or undetermined tumors); 8) Combine other severe unstable kidney, nervous system, endocrine diseases, thyroid diseases, urinary system, ophthalmic diseases, immune system, mental system, gastrointestinal, liver or blood system disease\u002Fabnormal history, as determined by the investigator, participation in this study may pose risks to the subjects or affect the analysis of research results; 9) During the screening period (visit 1), the investigator determines that the laboratory tests of the subjects show clinically significant abnormalities that may pose risks to the subjects, including but not limited to the following situations:\n\n    1. The glomerular filtration rate (eGFR) calculated using the CKD-EPI formula is less than 60 mL\u002Fmin\u002F1.73m2;\n    2. Liver function: Alanine aminotransferase (ALT) and\u002For aspartate aminotransferase (AST) are more than 2.5 times the upper limit of the normal value; Total bilirubin (TBIL) is more than 1.5 times the upper limit of the normal value.\n\n       10\\) Within 12 months before screening, received lobectomy or lung volume reduction surgery; 11) Had major surgery (requiring general anesthesia) within 6 weeks before screening, not fully recovered at the time of screening, or planned to undergo surgery before the end of the study; 12) Patients determined by the investigator to require oxygen therapy; 13）Have clinically significant apnea that requires the use of a continuous airway positive pressure ventilation (CPAP) device or non-invasive positive pressure ventilation (NIPPV) device;",{"count":120,"type":21},376,[78],"To evaluate the efficacy and safety of a 12-week administration of HSK39004 inhalation powder in clinical trial participants with COPD",[81],"2026-06-08",{"date":126,"type":34},"2026-06-10",{"date":128,"type":34},"2026-05-24",{"date":130,"type":21},"2027-10-30",{"name":40,"class":41},{"id":133,"slug":134,"hasResults":12,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":4,"eligibilityCriteria":138,"healthyVolunteers":12,"sex":17,"minAge":73,"maxAge":74,"enrollmentInfo":139,"targetDuration":4,"studyType":22,"phases":141,"briefSummary":143,"conditions":144,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":42},"100603731","phase-2-evaluation-of-the-safety-and-efficacy-of-hsk39004-dry-powder-inhaler-and-hsk39004-inhalation-suspension-in-chinese-patients-with-chronic-obstructive-pulmonary-disease-copd-100603731","NCT07140328","Evaluation of the Safety and Efficacy of HSK39004 Dry Powder Inhaler and HSK39004 Inhalation Suspension in Chinese Patients With Chronic Obstructive Pulmonary Disease (COPD)","A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase II Clinical Study to Evaluate the Efficacy and Safety of HSK39004 Dry Powder Inhaler and HSK39004 Inhalation Suspension in the Treatment of Chronic Obstructive Pulmonary Disease (COPD)","Inclusion Criteria:\n\n1. During the screening visit (Visit 1), the age range is 40 to 80 years (including the threshold value), and gender is not restricted;\n2. The subjects with chronic obstructive pulmonary disease (COPD) as per the GOLD 2025 diagnostic criteria, and the symptoms before screening were consistent with COPD for at least 1 year \\[GOLD 2025 standard: the subjects have chronic respiratory symptoms such as shortness of breath, chronic cough or expectoration, and\u002For have a history of exposure to risk factors, and the pulmonary function test results show: the forced expiratory volume in one second (FEV1) after using bronchodilators \u002F forced vital capacity (FVC) \\\u003C0.7\\];\n3. During the screening visit (Visit 1):\n\n   * FEV1\u002FFVC after using bronchodilators is \\\u003C0.7;\n   * 30% of the expected value ≤ FEV1 after using bronchodilators \\\u003C 80% of the expected value; Note: Using bronchodilators refers to using 400 μg (4 puffs, 100 μg per puff, with an interval of 1 minute between each puff) salbutamol inhalation aerosol for 15 to 30 minutes after use.\n4. Clinically stable COPD in the 4 weeks prior to screening (Visit 1);\n5. During the screening period and treatment period, COPD drugs prohibited by the protocol (except for salbutamol inhalation aerosol as a rescue drug) can be discontinued;\n6. Current smokers with a smoking quantity of ≥ 10 packs per year (smoking index (pack years) = daily smoking quantity (packs) × time (years), 1 pack = 20 cigarettes), or former smokers (for example: at least 1 pack per day, for 10 years), or those with a history of exposure to other risk factors.\n\nExclusion Criteria:\n\n1. Have received treatment for COPD acute exacerbation or been hospitalized for pneumonia within 12 weeks before screening;\n2. Have had acute (viral or bacterial) upper or lower respiratory tract infections or other infectious diseases requiring antibiotic treatment within 6 weeks before screening;\n3. Have other diagnosed respiratory system diseases other than COPD, including but not limited to: α-1 antitrypsin deficiency, asthma, active tuberculosis, lung edema, cystic fibrosis, bronchiectasis, pulmonary nodular disease, or clinically significant pulmonary fibrosis, pulmonary hypertension, interstitial lung disease, bronchiectasis (excluding asymptomatic local bronchial dilation);\n4. Have a history of or currently have severe cardiovascular diseases, including but not limited to:\n\n   * Screening period NYHA cardiac function grade III\u002FIV (according to the NYHA cardiac function grading standard, see Appendix 1);\n   * Had acute myocardial infarction, unstable angina pectoris\u002Facute coronary syndrome, percutaneous coronary intervention, coronary artery bypass grafting within 6 months before screening;\n   * Structural heart disease, such as hypertrophic cardiomyopathy, moderate to severe valvular disease;\n   * Had severe arrhythmia within 3 months before screening, such as: atrial fibrillation with a ventricular rate \\> 120 bpm, ventricular tachycardia, bradycardia (ventricular rate \\\u003C 45 bpm), second-degree II or above atrioventricular conduction block (excluding those with implanted pacemaker or defibrillator), male QTcF \\> 450 ms or female QTcF \\> 470 ms;\n   * Subjects with poor blood pressure control (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg at the screening visit);\n5. Have type I diabetes or poorly controlled type II diabetes (fasting blood glucose ≥ 10 mmol\u002FL at screening);\n6. Have cancer (in situ cancer that has been cured for more than 5 years, skin squamous cell carcinoma and basal cell carcinoma, etc., except for subjects with suspected malignant tumors or undetermined tumors);\n7. Combine other severe unstable kidney, nervous system, endocrine diseases, thyroid diseases, urinary system, ophthalmic diseases, immune system, mental system, gastrointestinal, liver or blood system disease\u002Fabnormal history, as determined by the investigator, participation in this study may pose risks to the subjects or affect the analysis of research results;\n8. During the screening period (visit 1), the investigator determines that the laboratory tests of the subjects show clinically significant abnormalities that may pose risks to the subjects, including but not limited to the following situations:\n\n   1. The glomerular filtration rate (eGFR) calculated using the CKD-EPI formula is less than 60 mL\u002Fmin\u002F1.73m2;\n   2. Liver function: Alanine aminotransferase (ALT) and\u002For aspartate aminotransferase (AST) are more than 2.5 times the upper limit of the normal value; Total bilirubin (TBIL) is more than 1.5 times the upper limit of the normal value.\n9. Lactose\u002Fmilk protein (dairy products) intolerance, allergy to HSK39004 or salbutamol or any known components in the administration system;\n10. Before the pulmonary function test during the screening (visit 1), any prohibited drugs in the protocol were used (see Table 4 and Table 5 of the prohibited drug list in Section 5.9.3);\n11. Within 12 months before screening, received lobectomy or lung volume reduction surgery;\n12. Had major surgery (requiring general anesthesia) within 6 weeks before screening, not fully recovered at the time of screening, or planned to undergo surgery before the end of the study;\n13. Patients determined by the investigator to require oxygen therapy;\n14. Have clinically significant apnea that requires the use of a continuous airway positive pressure ventilation (CPAP) device or non-invasive positive pressure ventilation (NIPPV) device;",{"count":140,"type":21},50,[142],"PHASE2","To evaluate the safety and efficacy of the HSK39004 Dry Powder Inhaler and HSK39004 Inhalation Suspension compared with the placebo in the treatment of Chinese patients with COPD.",[145],"Chronic Obstructive Lung Disease (COLD)",{"date":147,"type":34},"2026-06-09",{"date":149,"type":34},"2025-04-24",{"date":151,"type":21},"2026-08",{"name":40,"class":41},{"id":154,"slug":155,"hasResults":12,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":4,"eligibilityCriteria":159,"healthyVolunteers":12,"sex":17,"minAge":73,"maxAge":74,"enrollmentInfo":160,"targetDuration":4,"studyType":22,"phases":162,"briefSummary":163,"conditions":164,"keywords":165,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":42},"100643596","phase-3-long-term-safety-and-efficacy-of-hsk39004-inhalation-suspension-in-copd-100643596","NCT07634367","Long-Term Safety and Efficacy of HSK39004 Inhalation Suspension in COPD","A Multicenter, Single-Arm, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of HSK39004 Inhalation Suspension in Patients With Chronic Obstructive Pulmonary Disease (COPD)","Key Inclusion Criteria:\n\n1. 40 to 80 years (inclusive) at the time of screening visit (Visit 1), male or female;\n2. Subjects diagnosed with chronic obstructive pulmonary disease (COPD) in accordance with the GOLD 2026 diagnostic criteria prior to screening \\[GOLD 2026 criteria: presence of chronic respiratory symptoms such as dyspnea, chronic cough or sputum production, and\u002F or a history of risk factor exposure, and the pulmonary function test results show: the forced expiratory volume in one second (FEV1) after using bronchodilators \u002F forced vital capacity (FVC) \\\u003C0.7\\];\n3. At screening visit (Visit 1):\n\n   Post-bronchodilator FEV1\u002FFVC \\\u003C 0.7; and Post-bronchodilator FEV1 ≥ 30% and \\\u003C 80% of predicted value;\n4. Modified Medical Research Council (mMRC) dyspnea scale score ≥ 2 at screening;\n\nKey Exclusion Criteria:\n\n1. Subjects with unresolved lower respiratory tract infection occurring within 6 weeks prior to screening (Visit 1) and\u002For before enrollment;\n2. Severe or uncontrolled cardiovascular disease or history, including but not limited to: New York Heart Association (NYHA) functional class III\u002FIV at screening; acute myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to screening; clinically significant arrhythmia requiring intervention or marked QTcF prolongation (male \\>450 ms, female \\>470 ms) within 3 months prior to screening; or unstable or uncontrolled hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg) at screening;\n3. History of malignancy (except for carcinoma in situ, cutaneous squamous cell carcinoma, and basal cell carcinoma cured for more than 5 years), suspected malignancy, or undetermined neoplasm;\n4. Concurrent severe, uncontrolled renal, neurological, endocrine, thyroid, urological, ophthalmic, immunological, psychiatric, gastrointestinal, hepatic, or hematological diseases\u002Fabnormalities that, in the investigator's judgment, may pose a safety risk to the subject or confound study outcome analysis;\n5. Known hypersensitivity to HSK39004 inhalation suspention, salbutamol, or any component of the drug delivery system;\n6. Use of any protocol-prohibited medication prior to spirometry at screening (Visit 1);\n7. History of lung lobectomy or lung volume reduction surgery within 12 months prior to screening;\n8. Major surgery (requiring general anesthesia) within 6 weeks prior to screening with incomplete recovery, or planned surgery before study completion;\n9. Subjects determined by the investigator to require oxygen therapy;\n10. Clinically significant sleep apnea requiring continuous positive airway pressure (CPAP) or non-invasive positive pressure ventilation (NIPPV)",{"count":161,"type":21},300,[78],"This clinical trial evaluates the long-term safety and efficacy of 3 mg HSK39004 Inhalation Suspension administered twice daily for 52 weeks in subjects aged 40 to 80 years with moderate-to-severe stable chronic obstructive pulmonary disease (COPD).",[81],[83],"2026-06-03",{"date":124,"type":34},{"date":169,"type":21},"2026-07-10",{"date":171,"type":21},"2027-12-24",{"name":40,"class":41},{"id":174,"slug":175,"hasResults":12,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":4,"eligibilityCriteria":179,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":180,"targetDuration":4,"studyType":22,"phases":182,"briefSummary":183,"conditions":184,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":194},"100637065","phase-2-a-study-to-evaluate-the-long-term-safety-and-efficacy-of-hsk39297-tablets-in-primary-iga-nephropathy-100637065","NCT07616700","A Study to Evaluate the Long-Term Safety and Efficacy of HSK39297 Tablets in Primary IgA Nephropathy","A Multicenter, Open-Label Phase II Clinical Study to Evaluate the Long-Term Safety and Efficacy of HSK39297 Tablets in the Treatment of Primary IgA Nephropathy","Inclusion Criteria:\n\n1. Completed the HSK39297-202 study and assessed by the investigator to have a favorable benefit-risk profile for 200 mg QD HSK39297.\n2. eGFR ≥30 mL\u002Fmin\u002F1.73 m² at screening (calculated by CKD-EPI 2021 equation).\n3. Able to maintain optimized, stable background therapy with RAS blockers, SGLT2 inhibitors, endothelin receptor antagonists, or hydroxychloroquine during the study.\n4. Vaccinated against Neisseria meningitidis and Streptococcus pneumoniae as required in the previous study (booster if needed).\n5. Fertile females: negative serum pregnancy test; highly effective contraception from signing informed consent until 30 days after last dose.\n\n   Fertile males: highly effective contraception from signing informed consent until 90 days after last dose.\n6. Voluntarily provided written informed consent and able to comply with study procedures\n\nExclusion Criteria:\n\n1. Known or suspected hereditary or acquired complement deficiency.\n2. Active primary or secondary immunodeficiency.\n3. History of bone marrow \u002F hematopoietic stem cell or solid organ transplantation.\n4. Malignancy within the past 5 years (except cured basal cell carcinoma of the skin or carcinoma in situ of the cervix).\n5. History of recurrent invasive infections caused by encapsulated bacteria (e.g., N. meningitidis, S. pneumoniae) or Mycobacterium tuberculosis.\n6. Severe concomitant diseases judged by the investigator to be incompatible with study participation.\n7. Suspected hypersensitivity to the investigational product or its class.\n8. Pregnant or lactating females.\n9. Other conditions that may interfere with the study or increase subject risk.",{"count":181,"type":21},73,[142],"This is a Phase II, multicenter, open-label study. Eligible subjects who have completed the HSK39297-202 study will be enrolled.Starting dose is 200 mg QD.Dose may be increased to 300 mg QD after 8-12 weeks of stable 200 mg QD therapy if 24-h urine protein excretion (UPE) remains \\>1 g\u002F24 h and no Grade ≥3 treatment-related adverse events (AEs) occur.After the treatment period, subjects will enter the 4-week safety follow-up period.",[185],"IgA Nephropathy (IgAN)","2026-05-27",{"date":188,"type":34},"2026-06-01",{"date":190,"type":34},"2025-08-25",{"date":192,"type":21},"2026-12-26",{"name":40,"class":41},2,{"id":196,"slug":197,"hasResults":12,"nctId":198,"briefTitle":199,"officialTitle":200,"acronym":4,"eligibilityCriteria":201,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":202,"targetDuration":4,"studyType":22,"phases":204,"briefSummary":205,"conditions":206,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":207,"startDateStruct":209,"completionDateStruct":211,"leadSponsor":213,"locationsCount":214},"100622938","phase-3-phase--study-of-efficacy-and-safety-of-hsk39297-tablet-in-treatment-of-patients-with-primary-igan-100622938","NCT07390123","Phase Ⅲ Study of Efficacy and Safety of HSK39297 Tablet in Treatment of Patients With Primary IgAN","A Randomized, Double-blind, and Placebo-controlled Parallel Phase Ⅲ Clinical Study to Evaluate the Efficacy and Safety of HSK39297 Tablets in Treatment of Patients With Primary IgAN","Inclusion Criteria:\n\n1. Subjects must have signed and dated an IRB\u002FIEC approved written informed consent form.Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, tumor biopsies, and other requirements of the study.\n2. Female and male patients above 18 years of age.\n3. Patients must weigh at least 35 kg to participate in the study, and must have a body mass index (BMI) below 35 kg\u002Fm2. BMI = Body weight (kg) \u002F \\[Height (m)\\]2\n4. Subjects with a biopsy-verified IgA nephropathy and where the biopsy was performed within the prior ten years.\n5. 24h-UPCR ≥0.75g\u002Fg or 24h-UPE≥1.0g\u002F24h at screening.\n6. Measured Glomerular Filtration Rate (GFR) or estimated GFR (using the CKD-EPI formula 2021) ≥30 mL\u002Fmin per 1.73 m2.For patients with eGFR\\* 20 to \\\u003C30ml\u002Fmin\u002F1.73m2, a qualifying biopsy performed in two years.\n\nExclusion Criteria:\n\n1. Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 90 days, whichever is longer.\n2. All transplanted patients (any organ, including bone marrow).\n3. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in-situ cervical cancer).\n4. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the subject in case of participation in the study.\n5. Pregnant or nursing (lactating) women.\n6. Plasma donation (≥ 400mL) within 12 weeks prior to first dosing.",{"count":203,"type":21},370,[78],"Evaluate the efficacy and safety of HSK39297 tablets in patients with primary IgAN",[185],{"date":208,"type":34},"2026-05-28",{"date":210,"type":34},"2026-04-07",{"date":212,"type":21},"2028-07",{"name":40,"class":41},9,{"id":216,"slug":217,"hasResults":12,"nctId":218,"briefTitle":219,"officialTitle":220,"acronym":4,"eligibilityCriteria":221,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":222,"targetDuration":4,"studyType":22,"phases":224,"briefSummary":225,"conditions":226,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":228,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":194},"100633984","phase-2-a-clinical-trial-evaluating-the-efficacy-and-safety-of-hsk55718-in-patients-for-postoperative-pain-treatment-in-abdominal-surgery-100633984","NCT07533786","A Clinical Trial Evaluating the Efficacy and Safety of HSK55718 in Patients for Postoperative Pain Treatment in Abdominal Surgery","A Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of HSK55718 Injection for Postoperative Pain Treatment in Abdominal Surgery","Inclusion Criteria:\n\n* Age ≥18 years old, regardless of gender;\n* 18 kg\u002Fm2≤BMI≤30 kg\u002Fm2;\n* American Society of Anesthesiologists (ASA) gradeⅰ-ⅲ;\n* Accept abdominal surgery under general anesthesia;\n* Within 4 hours after the end of surgery, NRS≥4 in the resting state at any time;\n* Fully understand and voluntarily participate this trial, and sign the informed consent form;\n\nExclusion Criteria:\n\n* A history of cardiovascular, respiratory, neurological, or psychiatric diseases that meet the protocol-defined exclusion criteria.\n* Clinically significant abnormalities in laboratory tests during the screening period.\n* A history of severe drug allergy or known allergy to the investigational drug.\n* Continuous use of opioid analgesics for more than 10 days for any reason within 3 months prior to randomization.\n* Use of any medication that may affect analgesia, where the last dose was administered less than 5 half-lives of that drug before randomization.\n* A history of drug abuse, substance abuse, and\u002For alcohol abuse within the past year.\n* Pregnant or lactating women.\n* Participation in another drug clinical trial within 3 months prior to the screening period.\n* Presence of any sensory dysfunction.\n* Presence of any painful physical condition.\n* Subjects with any other factor considered by the investigator to be ineligible for participation in the trial.",{"count":223,"type":21},200,[142],"This is a multi-center, randomized, double-blind, double-dummy, placebo\u002Factive-controlled study. 200 subjects undergoing abdominal surgery under general anesthesia are planned to be enrolled and randomized into the HSK55718 group, morphine group, and placebo group.",[227],"Pain After Surgery",{"date":208,"type":34},{"date":230,"type":34},"2026-05-22",{"date":232,"type":21},"2026-11-22",{"name":40,"class":41},{"id":235,"slug":236,"hasResults":12,"nctId":237,"briefTitle":238,"officialTitle":239,"acronym":4,"eligibilityCriteria":240,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":241,"targetDuration":4,"studyType":22,"phases":243,"briefSummary":244,"conditions":245,"keywords":247,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":250,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":255,"locationsCount":42},"100640002","phase-3-a-study-to-assess-the-safety-of-hsk31858-in-participants-with-non-cystic-fibrosis-bronchiectasis-100640002","NCT07616375","A Study to Assess the Safety of HSK31858 in Participants With Non-Cystic Fibrosis Bronchiectasis","Phase 3 Single-arm, Open-label, Multicenter Study to Assess the Safety of HSK31858 in Participants With Non-cystic Fibrosis Bronchiectasis","Inclusion Criteria:\n\n* 1.Voluntarily sign the informed consent form; 2.Had previously participated in the HSK31858-301 study (having completed at least the randomization and having taken the first dose of medication); 3.If long-term treatment with bronchodilators (long-acting β-agonists and\u002For long-acting muscarinic antagonists) is required, the dose and regimen should remain stable throughout the study period.\n\n  4.Women must be post-menopausal, surgically sterile, or using highly effective contraception methods from Day 1 to at least 30 days after the last dose.\n\n  5\\. Males with female partners of childbearing potential must be using effective contraception from Day 1 to at least 90 days after the last dose.\n\nExclusion Criteria:\n\n* 1.In the HSK31858-301 study, there were cases of serious adverse events related to the investigational drug or subjects who were assessed by the investigators as requiring permanent discontinuation of the treatment.\n\n  2\\. Any other unstable clinical condition, including but not limited to cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematologic, psychiatric, or major physiological dysfunction, that the investigator considers to be (a) likely to affect patient safety throughout the study; (b) Influence the results of the study and its interpretation; (c) impeding the patient\\'s ability to complete the entire study.\n\n  3.Pregnancy and lactation. 4.The investigators judged that there were other conditions that were not suitable for participation in the study.",{"count":242,"type":21},669,[78],"This is a phase III, single-arm, open-label, multicenter study to assess the safety of HSK31858 in non-cystic fibrosis bronchiectasis (NCFBE) participants.",[246],"Non-cystic Fibrosis Bronchiectasis",[248],"non-cystic fibrosis bronchiectasis","2026-05-23",{"date":188,"type":34},{"date":252,"type":34},"2025-09-28",{"date":254,"type":21},"2029-04-03",{"name":40,"class":41},{"id":257,"slug":258,"hasResults":12,"nctId":259,"briefTitle":260,"officialTitle":261,"acronym":4,"eligibilityCriteria":262,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":263,"targetDuration":4,"studyType":22,"phases":265,"briefSummary":266,"conditions":267,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":270,"startDateStruct":272,"completionDateStruct":274,"leadSponsor":276,"locationsCount":194},"100636120","phase-1-phase-i-study-of-hsk42360-na-in-solid-tumors-with-braf-v600-mutation-100636120","NCT07561554","Phase I Study of HSK42360-Na in Solid Tumors With BRAF V600 Mutation","A Phase I, Open-label, Dose-escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic of HSK42360-Na in Patients With BRAF V600 Mutation Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n1. Age ≥ 18 years#Male and female patients, at time of signing informed consent form (ICF).\n2. ECOG performance status 0-1, or KPS (Karnofsky Performance Status) Score≥70.\n3. Life expectancy ≥ 3 months.\n4. Patients with locally advanced or metastatic solid tumors confirmed by histology or cytology, who have failed standard treatment (disease progression after treatment or intolerable treatment); patients who have previously received BRAF and\u002For MEK inhibitor therapy are allowed to be included in this study.\n5. Positive BRAF V600 mutation result confirmed prior to the administration of HSK42360-Na.\n6. Patients will provide blood or tumor sample according to their own willingness.\n7. Measurable or non-measurable disease by RECIST 1.1 or RANO criteria.\n8. Brain metastasis patients with inactive CNS lesions; Original intracranial tumor patient with inactive CNS lesions, or patients treated with ≤4mg\u002Fday corticosteroid and without convulsion for ≥2 weeks.\n9. Adequate hematologic, hepatic, and renal function.\n10. Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days after the last dose.\n\nExclusion Criteria:\n\n1. malignant tumor within 2 years, with the exception of cutaneous squamous cell carcinoma, cervical carcinoma in situ, papillary thyroid carcinoma, or other tumors with low malignancy.\n2. Uncontrollable pleural effusion, ascites, or pericardial effusion per protocol.\n3. Treatment with any of the following:\n\n   Prior treatment with anti-tumor drug within 4 weeks or approximately 5 × t1\u002F2 prior to the first dose of HSK42360-Na, whichever is shorter; Prior treatment with nitrosourea or mitomycin C within 6 weeks prior to the first dose of HSK42360-Na; Prior treatment with palliative radiotherapy or anti-tumor herbs within 2 weeks prior to the first dose of HSK42360-Na; Prior treatment with radiotherapy, electric field therapy, or other anti-tumor therapies within 4 weeks prior to the first dose of HSK42360-Na.\n4. Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 at the time of starting study treatment, with the exception of alopecia, dermal toxicity, and other toxicity considering no safety risks by investigator.\n5. Any disease which would preclude drug absorption, metabolism or pharmacokinetics, e.g. active peptic ulcer or chronic gastroesophageal reflux disease.\n6. Patients who have clinically significant or uncontrolled cardiac disease, include: QTc interval ≥ 450(male)\u002F470(female) msec; any clinically significant arrhythmia; left ventricular ejection fraction \\\u003C 50%; myocardial infarction, unstable angina, or class III\u002FIV cardiac failure by the NYHA that occurred within 6 months prior to the first dose of HSK42360-Na.\n7. Any thromboembolic events within 6 months prior to the first dose of HSK42360-Na; any familial or acquired thrombophilia.\n8. Uncontrolled hypertension (systolic pressure≥160mmHg, or diastolic pressure≥100mmHg), diabetes (fasting blood-glucose≥10mmol\u002FL), seizures, chronic obstructive pulmonary disease (COPD), interstitial pneumonia, pulmonary interstitial fibrosis, Parkinson's disease, active bleeding, or systemic active infection.\n9. Any unstable systemic disease, e.g. severe metabolic disease: liver cirrhosis, renal failure, or uremia.\n10. Treatment with inhibitors\u002Finducers for CYP3A4, or substrates of CYP3A4, CYP2C9, CYP2C8, OATP1B1, OATP1B3, OAT1, OAT3, P-gp or BCRP within 14 days or approximately 5 × t1\u002F2 prior to the first dose of HSK42360-Na, whichever is shorter.\n11. Patient with cognitive dysfunction, or history of mental illness, other uncontrolled comorbidities, alcohol dependence, hormone dependence or drug abuse.\n12. Autologous transplantation surgery within 3 months prior to the first dose of HSK42360-Na; Allogeneic transplantation, or stem-cell Transplant surgery within 6 months prior to the first dose of HSK42360-Na; Major surgery or significant traumatic injury occurring within 4 weeks prior to the first dose of HSK42360-Na.\n13. Patient with a history of immunodeficiency, including HIV positive, or other acquired\u002Fcongenital immunodeficiency diseases.\n14. Any disease of the eyes \\> CTCAE v5.0 Grade 1.\n15. Patient with active hepatitis B or hepatitis C.\n16. Patient with active syphilis infection.\n17. Allergic to any HSK42360-Na active constituent or ingredients.\n18. Participate in other clinical trials within 4 weeks prior to the first dose of HSK42360-Na.\n19. Positive pregnancy test, or breastfeeding.\n20. Any other circumstances that would, in the investigator's judgment, prevent the subject's participation in the clinical study due to safety concerns or compliance with clinical study procedures.",{"count":264,"type":21},159,[24],"This is a phase I, open-label, dose-escalation and expansion study to evaluate the safety, tolerability, PK and PD of HSK42360-Na when given orally in patients with active BRAF V600 mutation locally advanced or metastatic Solid Tumors.",[268],"Solid Tumors (Phase 1)","2026-04-27",{"date":271,"type":34},"2026-05-01",{"date":273,"type":34},"2026-03-06",{"date":275,"type":21},"2028-12-02",{"name":40,"class":41},{"id":278,"slug":279,"hasResults":12,"nctId":280,"briefTitle":281,"officialTitle":282,"acronym":4,"eligibilityCriteria":283,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":284,"targetDuration":4,"studyType":22,"phases":285,"briefSummary":286,"conditions":287,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":288,"lastUpdatePostDateStruct":289,"startDateStruct":290,"completionDateStruct":292,"leadSponsor":294,"locationsCount":4},"100635365","phase-2-a-clinical-trial-evaluating-the-efficacy-and-safety-of-hsk55718-in-patients-for-postoperative-pain-treatment-in-orthopedic-surgery-100635365","NCT07551739","A Clinical Trial Evaluating the Efficacy and Safety of HSK55718 in Patients for Postoperative Pain Treatment in Orthopedic Surgery","A Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of HSK55718 Injection for Postoperative Pain Treatment in Orthopedic Surgery","Inclusion Criteria:\n\nAge ≥18 years old, regardless of gender; 18 kg\u002Fm2≤BMI≤30 kg\u002Fm2; American Society of Anesthesiologists (ASA) gradeⅰ-ⅲ; Accept abdominal surgery under general anesthesia; Within 4 hours after the end of surgery, NRS≥4 in the resting state at any time; Fully understand and voluntarily participate this trial, and sign the informed consent form;\n\nExclusion Criteria:\n\nA history of cardiovascular, respiratory, neurological, or psychiatric diseases that meet the protocol-defined exclusion criteria.\n\nClinically significant abnormalities in laboratory tests during the screening period.\n\nA history of severe drug allergy or known allergy to the investigational drug. Continuous use of opioid analgesics for more than 10 days for any reason within 3 months prior to randomization.\n\nUse of any medication that may affect analgesia, where the last dose was administered less than 5 half-lives of that drug before randomization.\n\nA history of drug abuse, substance abuse, and\u002For alcohol abuse within the past year.\n\nPregnant or lactating women. Participation in another drug clinical trial within 3 months prior to the screening period.\n\nPresence of any sensory dysfunction. Presence of any painful physical condition. Subjects with any other factor considered by the investigator to be ineligible for participation in the trial.",{"count":223,"type":21},[142],"This is a multi-center, randomized, double-blind, placebo\u002Factive-controlled study. 200 subjects undergoing orthopedic surgery under general anesthesia are planned to be enrolled and randomized into the HSK55718 group, morphine group, and placebo group.",[227],"2026-04-20",{"date":269,"type":34},{"date":291,"type":21},"2026-04",{"date":293,"type":21},"2026-11",{"name":40,"class":41},{"id":296,"slug":297,"hasResults":12,"nctId":298,"briefTitle":299,"officialTitle":299,"acronym":4,"eligibilityCriteria":300,"healthyVolunteers":50,"sex":17,"minAge":18,"maxAge":301,"enrollmentInfo":302,"targetDuration":4,"studyType":22,"phases":304,"briefSummary":305,"conditions":306,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":308,"lastUpdatePostDateStruct":309,"startDateStruct":311,"completionDateStruct":313,"leadSponsor":314,"locationsCount":42},"100633027","phase-1-a-phase-i-study-to-evaluate-the-safety-tolerability-pharmacokinetics-and-the-food-effect-of-hsk55879-tablets-in-healthy-subjects-100633027","NCT07521345","A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and the Food Effect of HSK55879 Tablets in Healthy Subjects.","Inclusion Criteria:\n\n1. Able to understand the nature, purpose, and requirements of the study, as well as the potential risks and adverse reactions, and have signed the written informed consent form prior to the start of the study;\n2. Healthy subjects aged 18 to 45 years (inclusive) at screening, male or female;\n3. Body weight ≥50 kg for male subjects and ≥45 kg for female subjects at screening, with a body mass index (BMI) within the range of 19.0-28.0 kg\u002Fm² (inclusive);\n4. Subjects (including their partners) agree to have no pregnancy plan from 14 days before screening until 3 months after the last dose, and agree to use reliable contraceptive measures during this period.\n\nExclusion Criteria:\n\n1. Any history of disease that, in the investigator's judgment, may affect the safety evaluation of the subject or the in vivo disposition of the study drug,\n2. Physical examination, vital signs, laboratory tests，abdominal ultrasound, or chest X-ray findings that are judged by the study physician to be clinically significant abnormalities;\n3. Previous or current gastrointestinal, hepatic, renal, or other diseases known to interfere with drug absorption, distribution, metabolism, or excretion;\n4. abnormal HbA1c at screening;\n5. Abnormal liver function test results\n6. Estimated glomerular filtration rate (eGFR) calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation \\\u003C90 mL\u002Fmin\u002F1.73 m² at screening;\n7. Routine 12-lead electrocardiogram (ECG) findings that are not consistent with normal cardiac conduction and function.\n8. History of gastrointestinal diseases, with current symptoms of digestive discomfort ;\n9. Current or past history of drug abuse, or a positive urine drug screen at screening;\n10. Positive test for hepatitis B surface antigen (HBsAg), hepatitis C antibody, syphilis antibody, or human immunodeficiency virus (HIV) antibody at screening;\n11. Pregnant or breastfeeding females;\n12. Subjects who, in the investigator's opinion, have poor compliance or any other factor that makes them unsuitable for participation in this study.\n\n    \\-","45 Years",{"count":303,"type":21},46,[24],"This is a single-center, random, double blind, placebo control clinical study to evaluate the safety, tolerability pharmacokinetics and food effect of HSK55879 in healthy subjects",[307],"Healhty","2026-04-03",{"date":310,"type":34},"2026-04-09",{"date":312,"type":34},"2026-03-20",{"date":84,"type":21},{"name":40,"class":41},{"id":316,"slug":317,"hasResults":12,"nctId":318,"briefTitle":319,"officialTitle":319,"acronym":4,"eligibilityCriteria":320,"healthyVolunteers":12,"sex":17,"minAge":73,"maxAge":4,"enrollmentInfo":321,"targetDuration":4,"studyType":22,"phases":323,"briefSummary":324,"conditions":325,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":327,"lastUpdatePostDateStruct":328,"startDateStruct":329,"completionDateStruct":331,"leadSponsor":333,"locationsCount":4},"100632852","phase-3-a-multicenter-randomized-double-blind-placebo-controlled-phase-iii-study-to-evaluate-the-efficacy-and-safety-of-hsk44459-tablets-in-patients-with-idiopathic-pulmonary-fibrosis-100632852","NCT07519070","A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of HSK44459 Tablets in Patients With Idiopathic Pulmonary Fibrosis","Inclusion Criteria:\n\n1. Age ≥40 years, regardless of gender;\n2. Diagnosis of IPF confirmed prior to or during screening per the 2022 ATS\u002FERS\u002FJRS\u002FALAT guidelines (Appendix 1);\n3. Patients must meet one of the following criteria:\n\n   1. No treatment with nintedanib or pirfenidone for at least 8 weeks prior to screening (e.g., treatment-naïve or discontinued therapy), with no plans to initiate or resume antifibrotic treatment;\n   2. On a stable regimen of nintedanib or pirfenidone for at least 12 weeks prior to screening, without combination therapy with both drugs. \\[Stable therapy is defined as maintaining a constant dosage with tolerable drug-specific adverse events\\];\n4. Percentage predicted forced vital capacity (FVCpp) ≥45% at screening;\n5. Percentage predicted diffusing capacity of the lungs for carbon monoxide (DLCOpp) ≥25% and \\\u003C90% at screening \\[\\*hemoglobin (Hb)-adjusted\\];\n6. Willing to participate and voluntarily sign the informed consent form.\n\nExclusion Criteria:\n\n1. Clinically significant airway obstruction during screening \\[pre-bronchodilator forced expiratory volume in 1 second\u002Fforced vital capacity (FEV1\u002FFVC) \\\u003C0.7\\];\n2. Other clinically significant pulmonary abnormalities per investigator judgment (exceptions: conditions requiring no treatment during the trial, e.g., asymptomatic pulmonary nodules, emphysema);\n3. Acute IPF exacerbation within 3 months before screening and\u002For during screening;\n4. Receiving immunomodulators (excluding oral corticosteroids) for respiratory conditions, or prednisone \\>15 mg\u002Fday (or equivalent);\n5. History of vasculitis;\n6. Any suicidal behavior within 2 years before screening (actual attempt, interrupted attempt, aborted attempt, or preparatory acts\u002Fbehaviors);\n7. Type 4 or 5 suicidal ideation per Columbia-Suicide Severity Rating Scale (C-SSRS) within 3 months before\u002Fduring screening (active suicidal thoughts with method\u002Fintent but no plan, or with method\u002Fintent\u002Fplan);\n8. Respiratory infection requiring antibiotics or other infections requiring treatment within 4 weeks before\u002Fduring screening;\n9. Major surgery within 3 months before screening or planned during the study (investigator-assessed; lung transplant listing excluded);\n10. Malignancy within 5 years before screening (except treated basal cell carcinoma, squamous cell carcinoma in situ, or cervical carcinoma in situ);\n11. Blood pressure ≥160\u002F100 mmHg at screening;\n12. Unstable\u002Fworsening cardiovascular\u002Fcerebrovascular disease within 6 months before screening (e.g., unstable angina, myocardial infarction, heart failure, thromboembolic events including stroke\u002FTIA);\n13. Aspartate transaminase (AST) or alanine transaminase (ALT) \\>2.5×ULN or total bilirubin \\>1.5×ULN at screening;\n14. Estimated glomerular filtration rate (eGFR) ≤30 mL\u002Fmin\u002F1.73 m² at screening;\n15. Gastrointestinal surgery\u002Fdisease affecting pharmacokinetics (PK) (except appendectomy\u002Fhernia repair);\n16. Active hepatitis B \\[HBsAg-positive with HBV-DNA above ULN\\], hepatitis C antibody-positive, syphilis (anti-TP-positive with TRUST above ULN), or HIV infection (anti-HIV-positive) at screening;\n17. Current treated liver disease with Child-Pugh A\u002FB\u002FC impairment at screening;\n18. Substance abuse, drug use, or excessive alcohol intake (\\>2 units\u002Fday; 1 unit=360 mL beer \\[5%\\], 45 mL spirits \\[40%\\], or 150 mL wine) within 3 months before screening;\n19. Tobacco\u002Fnicotine product use within 3 months before screening or unwillingness to abstain during the study;\n20. Previous HSK44459 use or PDE1\u002F3\u002F4\u002F10\u002Fnon-selective PDE inhibitor treatment (excluding HSK44459, e.g., apremilast, roflumilast, ibudilast) within 8 weeks before screening;\n21. Use of strong CYP3A4 inhibitors\u002Finducers within 14 days or 5 half-lives (whichever longer) before first dose, or anticipated need during the study;\n22. History of severe drug allergy or hypersensitivity to investigational product\u002Fexcipients;\n23. Participation in other clinical trials (receiving investigational drug\u002Fplacebo) within 1 month before screening;\n24. Pregnancy\u002Flactation; participants of childbearing potential unwilling to use contraception during and for 3 months post-study (including male participants);\n25. Any other investigator-determined factors making participation unsuitable.",{"count":322,"type":21},420,[78],"This study aims to evaluate the efficacy and safety of HSK44459 tablets in patients with idiopathic pulmonary fibrosis (IPF).",[326],"IPF","2026-03-31",{"date":310,"type":34},{"date":330,"type":21},"2026-04-05",{"date":332,"type":21},"2028-12-30",{"name":40,"class":41},{"id":335,"slug":336,"hasResults":12,"nctId":337,"briefTitle":338,"officialTitle":339,"acronym":4,"eligibilityCriteria":340,"healthyVolunteers":12,"sex":17,"minAge":341,"maxAge":342,"enrollmentInfo":343,"targetDuration":4,"studyType":22,"phases":344,"briefSummary":345,"conditions":346,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":348,"lastUpdatePostDateStruct":349,"startDateStruct":351,"completionDateStruct":353,"leadSponsor":355,"locationsCount":4},"100632227","phase-3-hsk3486-cipepofol-injectable-emulsion-for-induction-of-general-anesthesia-in-pediatric-subjects-undergoing-elective-surgery-100632227","NCT07510945","HSK3486 (Cipepofol) Injectable Emulsion for Induction of General Anesthesia in Pediatric Subjects Undergoing Elective Surgery","A Multicenter, Randomized, Double-blinded, Propofol-controlled, Phase 3b Clinical Study to Evaluate the Efficacy and Safety of HSK3486 (Cipepofol) Injectable Emulsion for Induction of General Anesthesia in Pediatric Subjects Undergoing Elective Surgery","Inclusion Criteria:\n\n\\- 1. Subjects undergoing elective surgery requiring endotracheal intubation. 2. Males or females, aged ≥3 and \\\u003C18 years old, with ASA-PS I to IV. 3. For all females of childbearing potential, negative pregnancy test at screening and baseline. Additionally, females of childbearing potential must agree to use birth control (such as condom, intrauterine device \\[IUD\\], abstinence) from the time of consent until 30 days post study drug administration.\n\n4\\. Subjects must be able to adhere to the study visit schedule and complete all study assessments.\n\nExclusion Criteria:\n\n* 1\\. Subjects whose surgery is emergent, or who need emergency treatment during the surgery, or who need transfusion based on the investigator's judgment.\n\n  2\\. Contraindications to deep sedation\u002FGA or a history of adverse reaction to sedation\u002FGA.\n\n  3\\. Subjects known to be allergic to excipients in propofol injection, excipients in cipepofol injectable emulsion (soybean oil, glycerol, triglyceride, egg lecithin, sodium oleate and sodium hydroxide), benzodiazepines, opioids, rocuronium, atropine, and their active ingredients; and to have contraindications to propofol.\n\n  4\\. Subjects with history or evidence of any of sever system diseases increasing the risk of sedation\u002Fanesthesia prior to screening\u002Fbaseline and deemed unsuitable for participation by the investigator: 5. Subjects with respiratory tract management risks prior to\u002Fat screening. 6. Subjects who have participated in clinical studies of any drug within 1 month prior to screening.\n\n  7\\. Females of childbearing potential (i.e., post-menarche) who are unwilling to use contraception during the entire study period.\n\n  8\\. Subjects unsuitable for this study for any reason as judged by the investigator.","3 Years","17 Years",{"count":100,"type":21},[78],"This multicenter, randomized, double-blinded, propofol-controlled Phase 3b study enrolls pediatric subjects aged 3-17 years undergoing elective surgery with endotracheal intubation. Its primary purpose is to evaluate whether cipepofol is non-inferior to propofol in success of induction of general anesthesia in pediatrics undergoing elective surgery.",[347],"General Anesthetic","2026-03-29",{"date":350,"type":34},"2026-04-06",{"date":352,"type":21},"2026-05",{"date":354,"type":21},"2028-05",{"name":40,"class":41},{"id":357,"slug":358,"hasResults":12,"nctId":359,"briefTitle":360,"officialTitle":361,"acronym":362,"eligibilityCriteria":363,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":364,"targetDuration":4,"studyType":22,"phases":366,"briefSummary":367,"conditions":368,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":370,"lastUpdatePostDateStruct":371,"startDateStruct":372,"completionDateStruct":373,"leadSponsor":375,"locationsCount":4},"100631661","phase-3-evaluating-the-efficacy-and-safety-of-of-hsk44459-in-people-with-progressive-pulmonary-fibrosis-100631661","NCT07503587","Evaluating the Efficacy and Safety of of HSK44459 in People With Progressive Pulmonary Fibrosis","A Randomised, Double-blind, Placebo-controlled Parallel Group Phase III Clinical Study Evaluating the Efficacy and Safety of HSK44459 Tablets in Subjects With Progressive Pulmonary Fibrosis","PPF","Inclusion Criteria:\n\n1. Adults aged ≥18 year.\n2. Diagnosis of PPF other than IPF prior to screening or during the screening period.\n3. Patients must meet either of the following conditions:\n\n1\\. not on therapy with nintedanib or pirfenidone for at least 8 weeks prior to screening and during the screening period, and not planning to start or restart antiibrotic therapy.\n\n2.on stable therapy with nintedanib or pirfenidone for at least 12 weeks prior to screening and during the screening period.\n\n4.Percentage Predicted Forced Vital Capacity (ppFVC) ≥45% at screening period. 5.Diffusion capacity of the lung for carbon monoxide (DLCO) (corrected for haemoglobin \\[Hb\\]) ≥ 25% and \\\u003C90% of predicted normal at screening period .\n\nExclusion Criteria:\n\n1. Clinically significant airways obstruction (Forced Expiratory Volume in One Second (FEV1)\u002FForced Vital Capacity (FVC) \\\u003C 0.7) at screening.\n2. In the opinion of the Investigator, other clinically significant pulmonary abnormalities.\n3. Acute ILD exacerbation within 3 months prior to screening and\u002For during the screening period.\n4. History of malignancy within 5 years prior to screening.\n5. History of vasculitis.",{"count":365,"type":21},378,[78],"This study is open to adults with PPF . The main objective is to evaluate of the efficacy and the secondary objective is to evaluate the safety and pharmacokinetic.",[369],"Progressive Pulmonary Fibrosis","2026-03-25",{"date":327,"type":34},{"date":330,"type":21},{"date":374,"type":21},"2029-03-01",{"name":40,"class":41},{"id":377,"slug":378,"hasResults":12,"nctId":379,"briefTitle":380,"officialTitle":381,"acronym":4,"eligibilityCriteria":382,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":383,"enrollmentInfo":384,"targetDuration":4,"studyType":22,"phases":386,"briefSummary":387,"conditions":388,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":390,"lastUpdatePostDateStruct":391,"startDateStruct":393,"completionDateStruct":395,"leadSponsor":397,"locationsCount":42},"100618702","phase-2-a-study-for-hsk47388-in-participants-with-ulcerative-colitis-100618702","NCT07335055","A Study for HSK47388 in Participants With Ulcerative Colitis","A Phase 2 Randomized, Double-blind, Placebo-Controlled, Multicenter Clinical Study to Evaluate the Efficacy and Safety of HSK47388 in Participants With Moderately to Severely Active Ulcerative Colitis","Inclusion Criteria:\n\n1. Written informed consent must be obtained\n2. Male or female, ≥18 years old and ≤75 years old\n3. Willing and able to comply with study-specific procedures and the requirements of study protocol.\n4. Diagnosis of ulcerative colitis (UC)\n5. Baseline modified Mayo score of 5 to 9 and the endoscopy subscore 2 to 3\n6. Demonstrated an inadequate response, loss of response, or failure to tolerate previous conventional therapy or advanced therapy.\n\nExclusion Criteria:\n\n1. Subjects have used treatments within the time frame specified in protocol prior to the baseline visit\n2. Diagnosis of indeterminate colitis, ischemic colitis, Crohn's colitis or clinical findings suggestive of Crohn's disease\n3. Participants with current or prior diagnosis of fulminant colitis and\u002For toxic megacolon\n4. Presence of a stoma\n5. Presence or history of a fistula\n6. Intra-abdominal or other major surgery performed within 12 weeks before baseline\n7. History of extensive colonic resection\n8. Subjects have laboratory values meeting the criteria in protocol\n9. Concurrent conditions and history of other diseases as described in protocol","75 Years",{"count":385,"type":21},150,[142],"The purpose of this protocol is to evaluate the efficacy and safety of HSK47388 as therapy in participants with moderately to severely active ulcerative colitis .",[389],"Ulcerative Colitis (UC)","2026-03-03",{"date":392,"type":34},"2026-03-05",{"date":394,"type":34},"2026-02-03",{"date":396,"type":21},"2029-02-02",{"name":40,"class":41},{"id":399,"slug":400,"hasResults":12,"nctId":401,"briefTitle":402,"officialTitle":403,"acronym":4,"eligibilityCriteria":404,"healthyVolunteers":12,"sex":17,"minAge":73,"maxAge":74,"enrollmentInfo":405,"targetDuration":4,"studyType":22,"phases":406,"briefSummary":407,"conditions":408,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":409,"lastUpdatePostDateStruct":410,"startDateStruct":412,"completionDateStruct":414,"leadSponsor":416,"locationsCount":42},"100625636","phase-2-long-term-safety-and-efficacy-of-hsk39004-dry-powder-inhaler-in-copd-100625636","NCT07425210","Long-Term Safety and Efficacy of HSK39004 Dry Powder Inhaler in COPD","A Multicenter, Single-Arm, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of HSK39004 Dry Powder Inhaler in Patients With Chronic Obstructive Pulmonary Disease (COPD)","Key Inclusion Criteria:\n\n1. Aged 40 to 80 years (inclusive) at the time of screening visit (Visit 1), male or female;\n2. Subjects diagnosed with chronic obstructive pulmonary disease (COPD) in accordance with the GOLD 2026 diagnostic criteria prior to screening \\[GOLD 2026 criteria: presence of chronic respiratory symptoms such as dyspnea, chronic cough or sputum production, and\u002For a history of risk factor exposure, and the pulmonary function test results show: the forced expiratory volume in one second (FEV1) after using bronchodilators \u002F forced vital capacity (FVC) \\\u003C0.7\\];\n3. At screening visit (Visit 1):\n\n   * Post-bronchodilator FEV1\u002FFVC \\\u003C 0.7; and\n   * Post-bronchodilator FEV1 ≥ 30% and \\\u003C 80% of predicted value;\n4. Modified Medical Research Council (mMRC) dyspnea scale score ≥ 2 at screening;\n\nKey Exclusion Criteria:\n\n1. Subjects with unresolved lower respiratory tract infection occurring within 6 weeks prior to screening (Visit 1) and\u002For before enrollment;\n2. Severe or uncontrolled cardiovascular disease or history, including but not limited to: New York Heart Association (NYHA) functional class III\u002FIV at screening; acute myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to screening; clinically significant arrhythmia requiring intervention or marked QTcF prolongation (male \\>450 ms, female \\>470 ms) within 3 months prior to screening; or unstable or uncontrolled hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg) at screening;\n3. History of malignancy (except for carcinoma in situ, cutaneous squamous cell carcinoma, and basal cell carcinoma cured for more than 5 years), suspected malignancy, or undetermined neoplasm;\n4. Concurrent severe, uncontrolled renal, neurological, endocrine, thyroid, urological, ophthalmic, immunological, psychiatric, gastrointestinal, hepatic, or hematological diseases\u002Fabnormalities that, in the investigator's judgment, may pose a safety risk to the subject or confound study outcome analysis;\n5. Known hypersensitivity to HSK39004 inhalation powder, salbutamol, or any component of the drug delivery system;\n6. Use of any protocol-prohibited medication prior to spirometry at screening (Visit 1);\n7. History of lung lobectomy or lung volume reduction surgery within 12 months prior to screening;\n8. Major surgery (requiring general anesthesia) within 6 weeks prior to screening with incomplete recovery, or planned surgery before study completion;\n9. Subjects determined by the investigator to require oxygen therapy;\n10. Clinically significant sleep apnea requiring continuous positive airway pressure (CPAP) or non-invasive positive pressure ventilation (NIPPV);",{"count":161,"type":21},[142],"This clinical trial evaluates the long-term safety and efficacy of 0.75 mg HSK39004 Dry Powder Inhaler administered twice daily for 52 weeks in subjects aged 40 to 80 years with moderate-to-severe stable chronic obstructive pulmonary disease (COPD), including both newly enrolled and those who have completed prior participation in the HSK39004-201, HSK39004-T1-201, or HSK39004-T1-202 studies as a long-term extension.",[145],"2026-02-23",{"date":411,"type":34},"2026-02-25",{"date":413,"type":21},"2026-03",{"date":415,"type":21},"2027-08",{"name":40,"class":41},{"id":418,"slug":419,"hasResults":12,"nctId":420,"briefTitle":421,"officialTitle":422,"acronym":4,"eligibilityCriteria":423,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":424,"enrollmentInfo":425,"targetDuration":4,"studyType":22,"phases":427,"briefSummary":428,"conditions":429,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":431,"lastUpdatePostDateStruct":432,"startDateStruct":434,"completionDateStruct":436,"leadSponsor":438,"locationsCount":194},"100607274","phase-3-a-clinical-trial-evaluating-the-efficacy-and-safety-of-hsk21542-in-patients-for-postoperative-pain-treatment-in-orthopedic-surgery-100607274","NCT07186426","A Clinical Trial Evaluating the Efficacy and Safety of HSK21542 in Patients for Postoperative Pain Treatment in Orthopedic Surgery","A Multi-Center, Randomized, Double-Blind, Placebo\u002FActive-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of HSK21542 Injection for Postoperative Pain Treatment in Orthopedic Surgery","Inclusion Criteria:\n\n* 18 years old ≤ age ≤74 years old, regardless of gender;\n* 18 kg\u002Fm2≤BMI≤32 kg\u002Fm2，meet the weight range specified in the protocol；\n* American Society of Anesthesiologists (ASA) grade ⅰ-ⅲ;\n* Accept hip replacement under general anesthesia;\n* Within 4 hours after the end of surgery, NRS≥4 in the resting state at any time;\n* Fully understand and voluntarily participate this trial, and sign the informed consent form;\n\nExclusion Criteria:\n\n* Patients with allergy to opioids or any component of the trial drug；\n* Patients with a history of severe cardiovascular and cerebrovascular diseases, ,and psychiatric disorders;\n* Last use of opioid or non-opioid analgesics less than 5 half-lives or the duration of drug efficacy prior to randomization; use of drugs with unclear half-lives that may affect analgesic efficacy within 7 days prior to randomization, or last use of drugs affecting analgesic efficacy less than 5 half-lives prior to randomization, as well as Chinese herbal medicines or proprietary Chinese medicines deemed by the investigator as potentially impacting the evaluation of efficacy and safety；\n* Continuous use of opioid analgesics for more than 7 days for any reason within 30 days prior to screening;\n* Laboratory test results during the screening period meeting any of the following criteria: 1) Significantly abnormal hematology results; 2) Significantly abnormal prothrombin time test results; 3) Significantly abnormal liver or kidney function; 4) Significantly abnormal fasting blood glucose;\n* Positive test results during the screening period for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb), syphilis antibody, or human immunodeficiency virus (HIV) antibody;\n* A history of drug, drug, and\u002For alcohol abuse；\n* Participate in any clinical trail within 30 days;\n* Pregnant or lactating female subjects；\n* Subjects of childbearing potential who are unwilling to use contraception throughout the study period or plan to become pregnant within 3 months after the study.；\n* Subjects with any other factor considered by the investigator to be ineligible for participation in the trial.","74 Years",{"count":426,"type":21},405,[78],"This is a multi-center, randomized, double-blind, placebo\u002Factive-controlled study. 405 subjects undergoing orthopedic surgery under general anesthesia are planned to be enrolled and randomized into the HSK21542 group, morphine group, and placebo group.",[430],"Postoperative Pain Management","2026-02-11",{"date":433,"type":34},"2026-02-13",{"date":435,"type":34},"2025-07-28",{"date":437,"type":21},"2026-03-01",{"name":40,"class":41},{"id":440,"slug":441,"hasResults":12,"nctId":442,"briefTitle":443,"officialTitle":444,"acronym":4,"eligibilityCriteria":445,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":383,"enrollmentInfo":446,"targetDuration":4,"studyType":22,"phases":448,"briefSummary":449,"conditions":450,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":452,"lastUpdatePostDateStruct":453,"startDateStruct":455,"completionDateStruct":457,"leadSponsor":459,"locationsCount":42},"100620887","phase-2-study-to-assess-efficacy-and-safety-of-hsk39297-tablets-in-patients-with-ln-100620887","NCT07363460","Study to Assess Efficacy and Safety of HSK39297 Tablets in Patients With LN","A Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of HSK39297 Tablets in Patients With Lupus Nephritis","Inclusion Criteria:\n\n1. Understand and comply with the research requirements, voluntarily participate in the research and sign the informed consent form before starting the relevant procedures;\n2. Age ≥ 18 and \\\u003C 75 years old at screening, gender not limited;\n3. Positive anti-ANA antibody and\u002For anti-dsDNA antibody (research center);\n4. Pathological type of active III or IV lupus nephritis confirmed by renal biopsy within 12 months before screening, with or without type V (adopting the 2003 International Society of Nephrology\u002FRenal Pathology Working Group's lupus nephritis pathological classification criteria, see Appendix 2; for recurrent subjects, the investigator assesses whether a repeat renal biopsy is necessary; renal biopsy is conducted after confirming that the subject meets all other inclusion criterias and does not meet the exclusion criterias);\n5. Evidence of active lupus nephritis exists, and the investigator assesses that it is necessary to receive glucocorticoid combined with MMF treatment. Active lupus nephritis must meet the following two criterias:\n\n   a) Proteinuria:\n\n   a) At screening: 24h-UPCR ≥ 1g\u002Fg or FMV-UPCR ≥ 1g\u002Fg or FMV-UACR ≥ 0.5g\u002Fg; b) Before randomization: 24h-UPCR ≥ 1g\u002Fg (central laboratory); b) At screening: SLEDAI-2000 ≥ 8;\n6. First onset or recurrence of lupus nephritis (for subjects who have received MMF treatment previously and have experienced recurrence, the investigator and the sponsor jointly assess the benefit based on the study's medication regimen to determine whether they can be enrolled);\n7. Female subjects with reproductive capacity \\[excluding those who have undergone surgical sterilization (hysterectomy, bilateral tubal ligation, bilateral oophorectomy) at least 6 weeks prior to screening or who are postmenopausal (defined as having no menstruation for 12 months, with no other medical cause)\\]; a negative pregnancy test must be confirmed during the screening period. The subject must agree not to attempt pregnancy and not to donate oocytes from the date of signing the informed consent form until at least 30 days after the last administration of investigational product, and must use effective contraception; male subjects must agree not to donate sperm for at least 90 days from the date of signing the informed consent form until at least 90 days after the last administration of investigational product, and must use highly effective contraception with their female partners (see Appendix 3).\n\nExclusion Criteria:\n\n1. The subject has previously failed to respond to treatment with MMF or other mofetil mycophenolate drugs, as assessed by the investigator.\n2. Allergy to the investigational product or MMF, or contraindications to MMF and glucocorticoids.\n3. Currently receiving or requiring administration of any drug listed in Section 5.7.2.2 \"Prohibited Concomitant Medications\" during the study period.\n4. Receiving systemic glucocorticoid therapy for reasons other than systemic lupus erythematosus or lupus nephritis at screening (dose \\> 10 mg\u002Fday prednisone or equivalent; dosage conversion details see Appendix 4).\n5. Received treatment with other investigational drugs within 30 days prior to screening or within 5 half-lives (whichever is longer).\n6. Presence of rapidly progressive glomerulonephritis at screening (eGFR decline exceeding 50% within 3 months, or less than 50% but with rapid decline risk assessed by the investigator); renal biopsy showing crescents occupying more than 50% of glomeruli, or glomerulosclerosis exceeding 60%, or tubular atrophy\u002Finterstitial fibrosis exceeding 60%.\n7. Presence of severe extra-renal manifestations of systemic lupus erythematosus at screening, including but not limited to severe pulmonary hypertension (WHO classification IV or higher), severe pulmonary interstitial fibrosis, severe myocarditis, severe heart failure (NYHA classification IV), or active central nervous system lupus.\n8. Major, unstable, or uncontrolled acute or chronic diseases affecting various systems (e.g., cardiovascular, respiratory, hematological, gastrointestinal, hepatic, renal, neurological systems) within 6 months prior to screening or at screening that may affect study results or place the subject at high risk, excluding those caused by SLE.\n9. History of other autoimmune diseases.\n10. History of any of the following infections:\n\n1\\) History of encapsulated bacterial infection (e.g., Neisseria meningitidis, Streptococcus pneumoniae, Haemophilus influenzae) within 1 year prior to screening; 2) Active tuberculosis at screening; history of active tuberculosis within 2 years prior to screening; history of active tuberculosis currently cured but assessed by the investigator to be at risk for reactivation; positive interferon-gamma release assay with determination by the investigator or consulting specialist physician that it represents latent tuberculosis requiring prophylactic anti-tuberculosis treatment; 3) History of other active infections requiring antimicrobial treatment within 3 months prior to screening.\n\n11\\. History of major organ (heart, lung, kidney, liver) transplantation or hematopoietic stem cell\u002Fbone marrow transplantation, or planned for transplantation.\n\n12\\. Currently undergoing regular hemodialysis or planning to undergo hemodialysis during the study period.\n\n13\\. History of gastrointestinal surgery that may significantly affect drug absorption, distribution, metabolism, and excretion, or history of severe gastrointestinal disease, or difficulty in swallowing, frequent vomiting leading to difficulty in eating or taking medication.\n\n14\\. Diagnosis of malignancy within 5 years prior to screening, excluding basal cell carcinoma of the skin, papillary thyroid carcinoma, squamous cell carcinoma of the skin, or cervical carcinoma in situ.\n\n15\\. Major surgical procedures within 6 months prior to screening. 16. Laboratory tests at screening meet any of the following criteria:\n\n1. Estimated Glomerular Filtration Rate (eGFR) \\\u003C 30 ml\u002Fmin\u002F1.73m² (calculated by CKD-EPI 2021 formula, see Appendix 5);\n2. Hematology: neutrophils \\\u003C 1 × 10⁹\u002FL; leukocytes \\\u003C 2 × 10⁹\u002FL; hemoglobin \\\u003C 80 g\u002FL; platelets \\\u003C 50 × 10⁹\u002FL;\n3. Liver function: Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) ≥ 3 × ULN; Total Bilirubin (TBIL) ≥ 2 × ULN;\n4. Hepatitis B virus surface antigen (HBsAg) positive, or HBsAg negative but Hepatitis B virus core antibody (HBc-Ab) positive with HBV-DNA detection result higher than the quantitative lower limit; Hepatitis C virus antibody (HCV-Ab) positive;\n5. Human Immunodeficiency Virus antibody (HIV-Ab) positive. 17. Pregnant or lactating female subjects at screening. 18. Other situations deemed unsuitable for participation by the investigator.",{"count":447,"type":21},105,[142],"A double-blind,placebo controlled,randomized Phase 2 study to evaluate the safety and tolerability of once-daily, oral administration of 200 or 300 mg HSK39297 tablets versus placebo in Patients With Lupus Nephritis",[451],"Lupus Nephritis (LN)","2026-01-14",{"date":454,"type":34},"2026-01-23",{"date":456,"type":34},"2025-11-18",{"date":458,"type":21},"2028-07-06",{"name":40,"class":41},{"id":461,"slug":462,"hasResults":12,"nctId":463,"briefTitle":464,"officialTitle":465,"acronym":4,"eligibilityCriteria":466,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":467,"targetDuration":4,"studyType":22,"phases":469,"briefSummary":470,"conditions":471,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":473,"lastUpdatePostDateStruct":474,"startDateStruct":476,"completionDateStruct":478,"leadSponsor":480,"locationsCount":42},"100614761","phase-1-a-study-to-assess-pk-safety-and-efficacy-of-hsk47977-tablets-in-subjects-with-relapsed-or-refractory-non-hodgkins-lymphoma-100614761","NCT07283796","A Study to Assess PK, Safety and Efficacy of HSK47977 Tablets in Subjects With Relapsed or Refractory Non-Hodgkin's Lymphoma","A Phase I Clinical Study to Evaluate the Safety, Efficacy, and PK\u002FPD Characteristics of HSK47977 Tablets in Subjects With Relapsed or Refractory Non-Hodgkin's Lymphoma","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form.\n2. Age ≥18 years, with no gender restriction.\n3. Pathologically confirmed patients with relapsed\u002Frefractory Non-Hodgkin Lymphoma (rrNHL).\n4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2.\n5. Expected survival \\>3 months.\n6. Presence of measurable lesions.\n7. Adequate organ function.\n8. Agreement to undergo pathological tissue biopsy.\n9. Subjects of childbearing potential must agree to comply with the contraceptive requirements of the study.\n10. No pregnancy plans from screening until at least 3 months after the last dose of the study drug, and voluntary use of effective contraceptive measures.\n\nExclusion Criteria:\n\n1. Concurrent presence of other severe, unstable diseases\u002Fconditions that, in the investigator's judgment, make participation in this study unsuitable.\n2. History of or current severe cardiovascular disease.\n3. Poorly controlled blood pressure during the screening period.\n4. Laboratory abnormalities identified by the investigator that may pose a risk to the subject's safety.\n5. Electrocardiogram abnormalities determined by the investigator as potentially posing a risk to the subject's safety.\n6. History of allergies to the investigational drug or its excipients.\n7. Inability to discontinue prohibited medications as specified in the protocol during the screening period and throughout the entire study duration.\n8. Any other conditions that may increase subject risk or interfere with the trial results.\n9. Any other situations where the investigator deems the subject unsuitable for participation.",{"count":468,"type":21},110,[24],"This is a Phase I Clinical Study to Evaluate the Safety, Efficacy, and PK\u002FPD Characteristics of HSK47977 Tablets in Subjects with Relapsed or Refractory Non-Hodgkin's Lymphoma.This study includes a Phase Ia dose-escalation stage and a Phase Ib dose-expansion stage, and it is expected to take approximately 2 years.",[472],"NHL","2025-12-15",{"date":475,"type":34},"2025-12-19",{"date":477,"type":34},"2025-08-28",{"date":479,"type":21},"2027-12",{"name":40,"class":41},{"id":482,"slug":483,"hasResults":12,"nctId":484,"briefTitle":485,"officialTitle":485,"acronym":486,"eligibilityCriteria":487,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":488,"targetDuration":4,"studyType":22,"phases":489,"briefSummary":491,"conditions":492,"keywords":494,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":498,"lastUpdatePostDateStruct":499,"startDateStruct":501,"completionDateStruct":503,"leadSponsor":505,"locationsCount":42},"100602330","a-multicenter-randomized-open-label-parallel-controlled-clinical-study-comparing-the-efficacy-and-safety-of-cofrogliptin-versus-acarbose-in-drug-nave-patients-with-type-2-diabetes-100602330","NCT07122102","A Multicenter, Randomized, Open-Label, Parallel-Controlled Clinical Study Comparing the Efficacy and Safety of Cofrogliptin Versus Acarbose in Drug-Naïve Patients With Type 2 Diabetes","CARAT","Inclusion Criteria:\n\n* 1.Capable of understanding and voluntarily signing the written informed consent form.\n\n  2.Male or female aged ≥18 years (inclusive). 3.Fulfills diagnostic criteria for type 2 diabetes mellitus. 4.Previous glycemic control managed exclusively through diet and exercise therapy, with no prior exposure to any glucose-lowering or diabetes-related medications.\n\n  5.HbA1c at randomization: 7.0% ≤ HbA1c ≤ 9.0%. 6.Fasting plasma glucose (FPG) at randomization: FPG ≤ 11 mmol\u002FL. 7.Body mass index (BMI) at randomization: 18 ≤ BMI ≤ 35 kg\u002Fm². 8.Agrees to maintain consistent dietary and exercise habits throughout the trial period.\n\nExclusion Criteria:\n\n* 1.Known hypersensitivity to any component of the investigational product, chemically related compounds, or excipients.\n\n  2.History of diabetic ketoacidosis, type 1 diabetes, pancreatic\u002Fβ-cell transplantation, or diabetes secondary to pancreatitis\u002Fpancreatectomy.\n\n  3.Acute coronary syndrome (STEMI\u002FNSTEMI\u002Funstable angina), stroke, or transient ischemic attack (TIA) within 3 months prior to informed consent.\n\n  4.Congestive heart failure (NYHA Class III-IV). 5.Uncontrolled hypertension (systolic BP ≥180 mmHg or diastolic BP ≥110 mmHg). 6.Hepatic impairment: ALT, AST, or ALP \\>3×ULN at screening. 7.Severe renal impairment (eGFR \\\u003C25 mL\u002Fmin\u002F1.73m²). 8.Chronic gastrointestinal disorders with significant malabsorption. 9.Conditions potentially aggravated by intestinal gas (e.g., Roemheld syndrome, severe hernia, intestinal obstruction\u002Fulceration).\n\n  10.Bariatric surgery or malabsorptive gastrointestinal procedures within past 2 years.\n\n  11.Anti-obesity medications within 3 months prior to consent or weight instability at screening.\n\n  12.Malignancy (except basal cell carcinoma) within 5 years and\u002For active cancer therapy.\n\n  13.HIV infection. 14.Severe peripheral vascular disease. 15.Hematological disorders causing hemolysis\u002Ferythrocyte instability (e.g., malaria, babesiosis, hemolytic anemia).\n\n  16.Current systemic corticosteroid use, thyroid hormone dose changes within 6 weeks, or uncontrolled endocrine disorders (excluding T2DM).\n\n  17.Substance abuse within 3 months or chronic conditions potentially compromising compliance.\n\n  18.Pregnancy, lactation, or unwillingness to use effective contraception (females\u002Fmales).\n\n  19.Participation in other clinical trials within 30 days prior to screening. 20.Any other condition deemed unsuitable by the investigator.",{"count":223,"type":21},[490],"NA","This study will compare the effect and safety of cofrogliptin (HSK7653) with acarbose among people with type 2 diabetes",[493],"Type 2 Diabetes",[495,496,497],"cofrogliptin","acarbose","type 2 diabetes","2025-09-23",{"date":500,"type":34},"2025-09-26",{"date":502,"type":21},"2025-10-01",{"date":504,"type":21},"2027-07-30",{"name":40,"class":41},{"id":507,"slug":508,"hasResults":12,"nctId":509,"briefTitle":510,"officialTitle":511,"acronym":4,"eligibilityCriteria":512,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":513,"targetDuration":4,"studyType":22,"phases":514,"briefSummary":515,"conditions":516,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":518,"lastUpdatePostDateStruct":519,"startDateStruct":521,"completionDateStruct":523,"leadSponsor":525,"locationsCount":526},"100605145","phase-1-phase-i-study-of-hsk42360-in-malignant-brain-tumors-with-braf-v600-mutation-100605145","NCT07158710","Phase I Study of HSK42360 in Malignant Brain Tumors With BRAF V600 Mutation","A Phase I, Open-label, Dose-escalation and Expansion Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HSK42360 in Pediatric Patients With BRAF V600-Mutant Malignant Brain Tumors","Inclusion Criteria:\n\n1. Age ≥6 and \\\u003C18 years.\n2. Karnofsky\u002FLansky Performance Status \\>60.\n3. Life expectancy ≥ 3 months.\n4. Patients with recurrent malignant brain tumors confirmed by histology or cytology, who have failed standard treatment (disease progression after treatment or intolerable treatment); patients who have previously received BRAF and\u002For MEK inhibitor therapy are allowed to be included in this study.\n5. Positive BRAF V600 mutation result confirmed prior to the administration of HSK42360.\n6. Patients will provide blood or tumor sample according to their own willingness.\n7. Measurable disease by RANO criteria.\n8. Patients with inactive CNS lesions, or patients treated with ≤5mg\u002Fday corticosteroid and without convulsion for ≥2 weeks.\n9. Adequate hematologic, hepatic, and renal function.\n10. Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days after the last dose.\n\nExclusion Criteria:\n\n1. Patients with NF1 mutation.\n2. malignant tumor within 2 years, with the exception of cutaneous squamous cell carcinoma, cervical carcinoma in situ, papillary thyroid carcinoma, or other tumors with low malignancy.\n3. Uncontrollable pleural effusion, ascites, or pericardial effusion per protocol.\n4. Treatment with any of the following:\n\n   Prior treatment with anti-tumor drug within 4 weeks or approximately 5 × t1\u002F2 prior to the first dose of HSK42360, whichever is shorter; Prior treatment with nitrosourea or mitomycin C within 6 weeks prior to the first dose of HSK42360; Prior treatment with palliative radiotherapy or anti-tumor herbs within 2 weeks prior to the first dose of HSK42360; Prior treatment with radiotherapy, electric field therapy, or other anti-tumor therapies within 4 weeks prior to the first dose of HSK42360.\n5. Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 at the time of starting study treatment, with the exception of alopecia, dermal toxicity, and other toxicity considering no safety risks by investigator.\n6. Any disease which would preclude drug absorption, metabolism or pharmacokinetics, eg. active peptic ulcer or chronic gastroesophageal reflux disease.\n7. Patient who have clinically significant or uncontrolled cardiac disease, include: QTc interval ≥ 450 msec; any clinically significant arrhythmia; left ventricular ejection fraction \\\u003C 50%; myocardial infarction, unstable angina, or class III\u002FIV cardiac failure by the NYHA that occurred within 6 months prior to the first dose of HSK42360.\n8. Any thromboembolic events within 6 months prior to the first dose of HSK42360; any familial or aquired thrombophilia.\n9. Any unstable systemic disease, eg. severe metabolic disease: liver cirrhosis, renal failure, or uremia.\n10. Treatment with inhibitors\u002Finducers for CYP3A4, or substrates of CYP3A4, CYP2C9, CYP2C8, OATP1B1, OATP1B3, OAT1, OAT3, P-gp or BCRP within 14 days or approximately 5 × t1\u002F2 prior to the first dose of HSK42360, whichever is shorter.\n11. Patient with cognitive dysfunction, or history of mental illness, other uncontrolled comorbidities, alcohol dependence, hormone dependence or drug abuse.\n12. Autologous transplantation surgery within 3 months prior to the first dose of HSK42360; Allogeneic transplantation, or stem-cell Transplant surgery within 6 months prior to the first dose of HSK42360; Major surgery or significant traumatic injury occurring within 4 weeks prior to the first dose of HSK42360.\n13. Patient with a history of immunodeficiency, including HIV positive, or other acquired\u002Fcongenital immunodeficiency diseases.\n14. Patient with severe retinal abnormalities and uveitis.\n15. Patient with active hepatitis B or hepatitis C.\n16. Allergic to any HSK42360 active constituent or ingredients.\n17. Participate in other clinical trials within 4 weeks prior to the first dose of HSK42360.\n18. Positive pregnancy test, or breastfeeding.\n19. Any other circumstances that would, in the investigator's judgment, prevent the subject's participation in the clinical study due to safety concerns or compliance with clinical study procedures.",{"count":264,"type":21},[24],"This is a phase I, open-label, dose-escalation and expansion study to evaluate the safety, tolerability, PK of HSK42360 when given orally in pediatric patients with active BRAF V600 mutation recurrent malignant brain tumors.",[517],"Malignant Brain Tumors","2025-09-02",{"date":520,"type":34},"2025-09-08",{"date":522,"type":34},"2025-08-15",{"date":524,"type":21},"2029-12-03",{"name":40,"class":41},6,{"id":528,"slug":529,"hasResults":12,"nctId":530,"briefTitle":531,"officialTitle":532,"acronym":4,"eligibilityCriteria":533,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":534,"targetDuration":4,"studyType":22,"phases":536,"briefSummary":537,"conditions":538,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":477,"lastUpdatePostDateStruct":540,"startDateStruct":542,"completionDateStruct":544,"leadSponsor":546,"locationsCount":4},"100605111","phase-2-a-phase-2-study-of-hsk47388-tablets-to-evaluate-the-efficacy-and-safety-in-patients-with-moderate-to-severe-plaque-psoriasis-100605111","NCT07158268","A Phase 2 Study of HSK47388 Tablets to Evaluate the Efficacy and Safety in Patients With Moderate-to-Severe Plaque Psoriasis","A Phase 2 Multicenter, Randomized, Double-blind and Two-Stage Study to Evaluate the Efficacy and Safety of HSK47388 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis","Inclusion Criteria:\n\n1. Confirmed diagnosis of plaque psoriasis with a disease duration of at least 26 weeks before the first administration of the study intervention\n2. Total Body Surface Area (BSA) involvement ≥ 10% at both screening and baseline visits\n3. Psoriasis Area and Severity Index (PASI) total score ≥ 12 at both screening and baseline visits\n4. Investigator Global Assessment (IGA) for plaque psoriasis total score ≥ 3 (moderate or severe disease) at both screening and baseline visits\n5. Participants deemed appropriate candidates for systemic therapy for plaque psoriasis\n\nExclusion Criteria:\n\n1. Non-plaque psoriasis (e.g., erythrodermic, guttate, or pustular psoriasis)\n2. Current drug-induced psoriasis\n3. Current diagnosis, signs, or symptoms of severe, progressive, or uncontrolled disease involving the renal, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic systems\n4. Known allergy, hypersensitivity, or intolerance to HSK47388。\n5. A history of malignant tumor before screening;\n6. Subjects deemed unsuitable for participation due to other factors as determined by the investigator",{"count":535,"type":21},220,[142],"The primary objective of this study is to evaluate the efficacy of multiple-dose HSK47388 versus placebo in participants with moderate-to-severe plaque psoriasis.",[539],"Plaque Psoriasis",{"date":541,"type":34},"2025-09-05",{"date":543,"type":21},"2025-09-01",{"date":545,"type":21},"2027-01-17",{"name":40,"class":41},""]