[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Sichuan Huiyu Pharmaceutical Co., Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":192},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,42,65,85,106,130,151,171],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100637255","phase-1-bioequivalence-study-of-ferric-carboxymaltose-injection-in-healthy-chinese-participants-under-fasting-conditions-100637255",false,"NCT07606105","Bioequivalence Study of Ferric Carboxymaltose Injection in Healthy Chinese Participants Under Fasting Conditions","A Randomized, Open-label, Two-treatment, Two-period, Two-cross-over Bioequivalence Study of Ferric Carboxymaltose Injection in Healthy Chinese Participants Under Fasting Conditions","Inclusion Criteria:\n\n1. Participants must fully understand the purpose, nature, procedures, and potential adverse reactions of the study. They must voluntarily agree to participate in the trial, comply with all study requirements, and provide written informed consent before the initiation of any study procedures.\n2. Healthy male or female participants aged 18 to 55 years (inclusive).\n3. Participants must have a body weight of ≥ 50.0 kg; Body Mass Index(BMI) must range from 19.0 to 26.0 kg\u002Fm² (inclusive).\n4. Participants have been using effective contraception for 14 days prior to screening. Participants must agree to use highly effective contraceptive measures from screening until 3 months after the last administration. They must have no plans for pregnancy, sperm donation, or egg donation during this period.\n\nExclusion Criteria:\n\n1. Participants with allergic conditions, such as a known history of hypersensitivity to two or more medications; known allergies to iron, maltose, or its analogues\u002F metabolites; or a history\u002Fpresence of severe asthma, eczema, or other atopic allergic disorders.\n2. History\u002Fpresence of iron storage diseases (e.g., hemochromatosis), iron utilization disorders (e.g., iron-refractory iron deficiency anemia), hemoglobinopathies (e.g., thalassemia), hemolytic anemia, symptomatic anemia requiring red blood cell infusion, or undergoing hemodialysis.\n3. History of iron deficiency or anemia within 6 months prior to screening.\n4. History of clinically significant chronic or severe conditions affecting the respiratory, cardiovascular, gastrointestinal, renal, hematological, lymphatic, endocrine, immune, psychiatric, or nervous systems; past or current diagnosis of porphyria cutanea tarda; or other conditions deemed by the investigator to be unsuitable for participation.\n5. Acute conditions (e.g., acute infection, acute gastrointestinal disorders such as nausea, vomiting, diarrhea, or constipation, etc.) within 2 weeks prior to the first dose.\n6. Participants with clinically significant abnormalities in vital signs, physical examination, laboratory tests (e.g., hematology, urinalysis, blood chemistry, coagulation function tests, iron metabolism assessments), infectious disease testing, or 12-lead Electrocardiogram (ECG), as determined by the investigator (special requirement: calcium and phosphorus values in blood chemistry tests are in the abnormal range). Hepatic enzyme levels exceeding 1.5 times the upper limit of normal (ULN) during screening. Serious arrhythmias shown in ECG at screening, such as recurrent or symptomatic ventricular tachycardia, atrial fibrillation accompanied by rapid ventricular response, or supraventricular tachycardia.\n7. History of hypersensitivity or intolerance to intravenous iron administration.\n8. Receiving parenteral iron treatment within 6 months prior to screening, erythropoiesis-stimulating agent (ESA) therapy and\u002For blood transfusion within 4 weeks prior to screening.\n9. Use of any medication that may affect iron absorption iron absorption within 28 days prior to dosing, such as antacids (e.g., omeprazole), tetracycline antibiotics, calcium supplements, or lipid-lowering agents (e.g., cholestyramine).\n10. Use of any medications (prescription, over-the-counter, herbal remedies, or dietary supplements) and healthcare products within 2 weeks prior to screening.\n11. History of smoking an average of more than 5 cigarettes per day within 3 months prior to screening or unwillingness to abstain from smoking from 48 hours prior to dosing until the completion of blood sampling in each treatment period.\n12. Participants who have undergone surgeries within 6 months prior to screening that might affect drug absorption, distribution, metabolism and excretion, or planning to undergo surgeries during the study.\n13. Participants who have enrolled in other clinical trials and received investigational products or devices within 3 months prior to screening.\n14. Blood donation or significant blood loss due to other reasons within 3 months prior to screening (\\> 400 mL, excluding menstrual blood loss in female participants), or donated platelets in an amount equal to or exceeding 2 therapeutic doses (1 therapeutic dose = 12 units of platelets) within 1 month prior to screening, or plan to donate blood during the study.\n15. Participants with drug abuse history (including the use of various anesthetic and psychotropic drugs for non-medical purposes) within 1 year prior to screening or have a positive drug abuse screening result.\n16. Participants with history of alcohol abuse within 1 year prior to screening, defined as average daily alcohol consume over 2 units (1 unit = 360 mL beer, 45 mL spirits with 40% alcohol, or 150 mL wine), or are unwilling to abstain from alcohol or alcohol-containing products from 48 hours prior to dosing until the completion of blood sampling in each treatment period, or have positive breath alcohol test result.\n17. Participants who have special diet: xanthine-rich foods (e.g., coffee, chocolate, tea or cocoa beverages), iron-rich foods including animal organs, animal blood, spinach, as well as calcium\u002Fphosphorus-rich seafood, shellfish, crab, and nuts such as peanuts and sunflower seeds, dragon fruit, mango, grapefruit or grapefruit-containing products, or taking strenuous exercise, or other factors affecting drug absorption, distribution, metabolism, and excretion, within 48 hours before receiving the first dose of investigational product.\n18. Participants who received a live vaccine within 14 days prior to screening, or plan to receive vaccination during the study.\n19. Inability to tolerate venipuncture or history of fear of needles or hemophobia.\n20. Participants with special dietary requirements, and participants who cannot accept the study standardized diet.\n21. Any other condition deemed by the investigator to be unsuitable for enrollment.\n\n    In addition to the aforementioned requirements, females who meet the following conditions should also be excluded:\n22. Use of oral contraceptives within 30 days prior to screening.\n23. Use of long-acting estrogen or progestin injections (progestin-based intrauterine devices), or implants within 6 months prior to screening.\n24. Pregnancy, breastfeeding, or positive pregnancy test at screening.",true,"ALL","18 Years","55 Years",{"count":21,"type":22},70,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","The goal of this clinical trial is to compare the pharmacokinetic profile of the developed drug product and reference product in healthy participants under fasting condition. The main questions it aims to answer are:\n\n* \\[Question 1\\] Is there significant difference in the pharmacokinetic profile between the ferric carboxymaltose injection 750 mg iron\u002F15 mL provided by Sichuan Huiyu Pharmaceutical Co., Ltd. and the ferric carboxymaltose injection licensed by American Regent, Inc. (trade name: Injectafer®, strength:750 mg iron\u002F15 mL )?\n* \\[Question 2\\] Is it safe for healthy participants to take ferric carboxymaltose injection (750 mg iron\u002F15 mL \\[calculated by iron\\]) provided by Sichuan Huiyu Pharmaceutical Co., Ltd. under fasting condition? Participants will be randomly divided into two groups by stratified blocked randomization, with equal number of healthy participants in each group, to receive test product or reference product according to the protocol below.\n* Dosing on D1: Group T (Test product) Group R (Reference product)\n* PK blood sample collection\n* Safety evaluation",[28],"Healthy Adult","RECRUITING","2026-05-18",{"date":32,"type":33},"2026-05-26","ACTUAL",{"date":35,"type":22},"2026-05-19",{"date":37,"type":22},"2027-01-26",{"name":39,"class":40},"Sichuan Huiyu Pharmaceutical Co., Ltd","INDUSTRY",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":23,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":41},"100598251","phase-1-a-phase-i-human-study-of-hy0001a-for-injection-in-adult-participants-with-advanced-solid-tumors-100598251","NCT07069062","A Phase I\u002FⅡ Human Study of HY0001a for Injection in Adult Participants With Advanced Solid Tumors","A Multicenter, Open-label Phase I\u002FII Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Clinical Efficacy of HY0001a for Injection in Patients With Advanced Malignant Solid Tumors","Inclusion Criteria:\n\n* Voluntarily sign an informed consent form, understand the study and be willing and able to follow and complete all trial procedures;\n* ≥18 years old and ≤75 years old, gender: male or female;\n* Patients have histological or cytological diagnosis with advanced solid tumors, cann't benefit from existing standard treatment options;The solid tumors included in the dose-expansion phase are as follows: Cohort 1: Esophageal cancer (patients who have previously received at least two lines of standard therapy);Cohort 2: Non-small cell lung cancer (patients who have previously received at least two lines of standard therapy);Cohort 3: Other tumors, such as cervical cancer, squamous cell carcinoma of the head and neck, pancreatic cancer, gastric adenocarcinoma, gastroesophageal junction adenocarcinoma, breast cancer, etc. (patients who have failed or are intolerant to standard therapy).\n* In the dose-escalation phase, patients must have evaluable tumor lesions; in the dose-expansion phase, patients must have at least one measurable tumor lesion (according to RECIST 1.1 version);\n* In the dose-escalation phase, enrollment does not require the expression of CDCP1 (CUB domain containing protein 1). In the dose-expansion phase, enrollment is required to be positive for CDCP1\n* Eastern Cooperative Oncology Group (ECOG) performance status score is 0 or 1;\n* Life expectancy ≥3 months;\n* Participant must have adequate main organ function;\n* Fertile female patients must have a negative serological pregnancy test within 7 days before the first dosing and be willing to use effective birth control\u002Fcontraception to prevent pregnancy during the study period up to 6 months after the last dosing of the study. Male patients must agree to have no sperm donation plans and to use effective contraceptive methods during the study period until 6 months after the last dose of the study. Postmenopausal women must have amenorrhea for at least 12 months before they are considered infertile.\n\nExclusion Criteria:\n\n* Having received anti-tumor treatments such as chemotherapy, radiotherapy, biological therapy, endocrine therapy, or immunotherapy within 4 weeks prior to the first administration of the study drug\n* Known history of severe allergic reactions, or individuals who have experienced an allergic reaction to any of the excipients in the formulation of HY0001a for injection\n* Participants who have previously failed treatment with antibody-drug conjugates (ADCs) that use microtubule inhibitors (Monomethyl auristatin E\u002FMonomethyl auristatin F) as toxins\n* Participants who have received other investigational drugs or participated in interventional medical device studies within 4 weeks prior to the first administration of the study drug;\n* Participants who have received (attenuated) live vaccines within 4 weeks prior to the first administration of the study drug;\n* Participants who have undergone major organ surgery (excluding biopsy) within 4 weeks prior to the first administration of the study drug or have experienced significant trauma, or who require elective major organ surgery (excluding biopsy) during the study period;\n* Participants who are currently receiving, or who have received treatment with strong CYP3A4 or P-gp inducers or inhibitors within at least one week or five half-lives (whichever is longer) prior to the first administration of the study drug (limited to the dose-escalation phase).\n* Participants with uncontrolled, unstable, or active central nervous system (CNS) metastases detected by computed tomography (CT) or magnetic resonance imaging (MRI) during the screening period and before radiological assessment\n* Participants with clinically uncontrollable hypertension (defined in this protocol as having a systolic blood pressure \\> 150 mmHg and\u002For a diastolic blood pressure \\> 100 mmHg despite antihypertensive treatment, and which is considered clinically significant by the investigator);\n* Participants who have received allogenic tissue\u002Forgan transplants in the past;\n* Known human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS);Active or chronic hepatitis B or hepatitis C infection; treponema pallidum antibody positive, and confirmed positive test;\n* Presence of ophthalmic diseases or symptoms that are deemed by the investigator as not meeting the eligibility criteria at the screening stage.\n* Presence of sensory and\u002For motor neuropathy of Grade ≥2 during the screening period (according to CTCAE Version 5.0)\n* Individuals with any of the following cardiac conditions: a. Left ventricular ejection fraction (LVEF) ≤ 50% (Echocardiography, abbreviated as ECHO); New York Heart Association (NYHA) Class III or IV congestive heart failure; b. Significant arrhythmias requiring treatment, including a QTcF (corrected QT interval) ≥ 480 ms measured by electrocardiogram (ECG) (QTcF = QT\u002F(RR\\^0.33)); c. History of myocardial infarction, unstable angina, or clinically significant valvular disease within 6 months prior to dosing; other cardiac diseases deemed by the investigator as unsuitable for enrollment.\n* Presence of other diseases that severely endanger the safety of the participant or affect the participant's ability to complete the trial, such as active gastrointestinal bleeding, active peptic ulcer, intestinal obstruction, intestinal ileus, renal failure, and uncontrolled diabetes (glycated hemoglobin (HbA1c) \\> 8% during the screening period)\n* Participants with active infections deemed inappropriate for entry into the study by the investigator;\n* Participants with uncontrolled third-space effusion requiring clinical intervention;\n* Participants with a history of drug abuse or medical, psychological, or social conditions that may interfere with study participation or impair the assessment of study outcomes;\n* Participant whose toxicities from previous anti-cancer therapy have not resolved, defined as toxicity (hair loss excluded) that has not resolved to grade ≤1 (CTCAE 5.0 version, peripheral neuropathy, ≤grade 2; exclusion criteria specified);\n* Female participants who are breastfeeding or have positive urine or blood pregnancy test results during the screening period; female participants who have a planned pregnancy, sperm donation, or egg donation during the study period or within 6 months after the last study drug administration;\n* Known history of hypersensitivity to any of the components of the test formulation.\n* Participants who have had other malignancies within the past 5 years, excluding cured cervical carcinoma in situ, basal cell carcinoma of the skin or squamous cell carcinoma of the skin.","75 Years",{"count":51,"type":22},261,[25,53],"PHASE2","This is a multicenter, open-label, phase I\u002FⅡ study to evaluate the safety, efficacy, and pharmacokinetic (PK)\u002Fpharmacodynamic(PD) characteristics of HY0001a for injection in participants with advanced solid tumors.",[56],"Solid Tumor","2026-03-05",{"date":59,"type":33},"2026-03-09",{"date":61,"type":33},"2025-07-21",{"date":63,"type":22},"2027-09",{"name":39,"class":40},{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":49,"enrollmentInfo":72,"targetDuration":4,"studyType":23,"phases":74,"briefSummary":76,"conditions":77,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":79,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":41},"100574923","bioequivalence-study-of-paclitaxel-for-injection-albumin-bound-in-subjects-with-breast-cancer-100574923","NCT06765590","Bioequivalence Study of Paclitaxel for Injection (Albumin Bound) in Subjects With Breast Cancer","A Randomized, Open-label, Single-dose, Two-period, Two-way Crossover Bioequivalence Study of Paclitaxel for Injection (Albumin Bound) in Subjects With Breast Cancer","Inclusion Criteria:\n\n1. Subjects voluntarily participate in the study and sign the informed consent forms (ICFs);\n2. Patients with breast cancer confirmed by histopathology and\u002For cytology who meet one of the following conditions: ① with metastatic breast cancer that does not respond to combination chemotherapy or recurrent breast cancer within 6 months after adjuvant chemotherapy, and an anthracycline anticancer drug should be used in the previous chemotherapy unless clinically contraindicated; ② investigators determine that subjects are candidates for albumin-bound paclitaxel by reference to the treatment guidelines (NCCN Guidelines and CSCO Guidelines for breast cancer);\n3. Aged 18-75 years old (both inclusive), males or females; body mass index (BMI) ≥17 (BMI = weight (kg)\u002Fheight (m2));\n4. The ECOG score is 0-2;\n5. The expected survival time is ≥3 months;\n6. Subjects have no plans to become pregnant and voluntarily use non-pharmacologic contraception (such as total abstinence, condom, contraceptive ring, vasectomy, etc.) or other highly effective contraceptive methods, and have no plans to donate eggs or sperm throughout the trial and within 6 months after the last dose;\n7. Subjects with the laboratory test results as follows: hemoglobin (Hb) ≥80 g\u002FL (no blood transfusion within 14 days), absolute neutrophil count (ANC) ≥1.5 \\* 109\u002FL, platelet count (PLT) ≥100 \\* 109\u002FL; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 times the upper limit of normal value (for patients without liver metastasis) or ≤5 times the upper limit of normal value (for patients with liver metastasis); total bilirubin (TBIL) ≤1.5 times the upper limit of normal value (for patients without liver metastasis) or ≤3 times the upper limit of normal value (for patients with liver metastasis); serum creatinine clearance ≥60 mL\u002Fmin \\[formula: Ccr: (140 - age) \\* body weight (kg) \\* 0.85 (if female)\u002F0.818 \\* Scr (μmol\u002FL)\\]; international normalized ratio (INR) ≤1.5 times the upper limit of normal value;\n8. Subjects are able to communicate well with the investigator and understand and comply with the requirements of the study.\n\nExclusion Criteria:\n\n1. Subjects with allergic constitution (excluding mild asymptomatic seasonal allergies), or who are known (or suspected) to be allergic to or have a specific reaction to the active ingredient paclitaxel or excipients, albumin;\n2. Subjects who have received radiotherapy, chemotherapy, immunotherapy and endocrinotherapy within 4 weeks before the administration of the investigational drug and still respond to the treatment;\n3. Subjects who have suffered from serious illness of cardio-cerebral vascular system, lung, liver, kidney, gastrointestinal tract, endocrine system, immune system, skin, musculoskeletal system and nervous system or psychiatric disorders within 3 months before screening and are considered unsuitable for enrollment by the investigator;\n4. Subjects who have undergone major surgery or suffered from fracture within 4 weeks prior to screening, or plan to undergo major surgery during the study;\n5. Subjects who have received treatment with other investigational drugs within 4 weeks before the study;\n6. Subjects who have used substrates, inducers or inhibitors of CYP2C8 or CYP3A4 enzymes (including but not limited to ketoconazole and other imidazole antifungal agents, verapamil, diazepam, quinidine, dexamethasone, cyclosporine, teniposide, etoposide, vincristine, testosterone, 17-α diethylstilbestrol, retinoic acid, quercetin, erythromycin, fluoxetine, gemfibrozil, cimetidine, ritonavir, saquinavir, indinavir, nelfinavir, rifampicin, carbamazepine, phenytoin, efavirenz, nevirapine, etc.) in concomitant medications within 4 weeks prior to the first dose of the investigational drug or fail to suspend medications during the study (except for stable dosing at steady state, i.e. the dosing regimen remains unchanged);\n7. Subjects who have consumed special diet (foods that affect the activity of CYP3A4 or CYP2C8 enzyme, such as grapefruit, pomelo, mango, etc.), exercised vigorously or with other factors that may affect drug absorption, distribution, metabolism and excretion within 48 hours before the administration of the investigational drug;\n8. Subjects who have received therapy with the granulocyte colony-stimulating factor (G-CSF) within 2 weeks before screening;\n9. Subjects with grade 2 or higher sensory neuropathy\u002Fperipheral neuropathy at screening;\n10. Subjects who have experienced myocardial infarction (within 6 months before the study), severe or unstable angina, and grade III-IV heart failure according to the New York Heart Association (NYHA) Classification, or underwent coronary or peripheral artery bypass grafting;\n11. Subjects with poorly controlled hypertension (with the systolic blood pressure of \\>160 mmHg and\u002For diastolic blood pressure of \\>100 mmHg under regular medication);\n12. Subjects who have bleeding tendency or are receiving thrombolytic or anticoagulant therapy or have donated or lost more than 400 mL of blood within 3 months before the administration of the investigational drug;\n13. Subjects with clinically significant 12-lead ECG abnormalities, who are considered unsuitable for enrollment by the investigator;\n14. Subjects with a history of alcohol (drinking more than 14 units of alcohol per week within 6 months prior to the first dose: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine), drug abuse (using narcotic drugs or psychotropic drugs for non-medical purposes) or addiction to drugs, who smoked more than 5 cigarettes per day within 3 months prior to screening, or who could not stop smoking or drinking during the period from signing the ICFs to completing the bioequivalence study;\n15. Subjects with positive results of hepatitis B surface antigen (HBsAg), HBV DNA, hepatitis C core antibody (HCV-cAg), HCV RNA, HIV antibody, treponema pallidum antibody, or rapid plasma reagin (RPR) test;\n16. Pregnant or lactating women;\n17. Other conditions judged inappropriate for participation by the investigator.",{"count":73,"type":22},24,[75],"NA","This study was a multicenter, randomized, open, single-dose, two-cycle, two-cross-dosing human bioequivalence trial designed to evaluate the bioequivalence of tested and reference preparations in breast cancer subjects.",[78],"Breast Cancer",{"date":59,"type":33},{"date":81,"type":33},"2025-03-12",{"date":83,"type":22},"2026-10-30",{"name":39,"class":40},{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":92,"enrollmentInfo":93,"targetDuration":4,"studyType":23,"phases":95,"briefSummary":96,"conditions":97,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":99,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},"100574223","phase-1-a-phase-i-study-of-hy-2003-in-the-subjects-with-excessive-submental-fat-accumulation-100574223","NCT06756490","A Phase I Study of HY-2003 in the Subjects With Excessive Submental Fat Accumulation","A Prospective, Blinded (Evaluators and Subjects Blinded), Randomized Controlled Phase I Clinical Trial to Evaluate the Safety, Efficacy and Pharmacokinetics of Liposome-encapsulated Deoxycholic Acid for Injection (HY-2003) Administered by Subcutaneous Fat Layer Injection in the Subjects With Excessive Submental Fat Accumulation","Inclusion Criteria:\n\n1. Fully understand the requirements of the trial, and signed the informed consent form voluntarily;\n2. The subjects should have good compliance, are able to fully understand this clinical trial, have reasonable expectations for the injection effects, and can abide by the research procedures until the end of the clinical trial.\n3. Aged 18 to 65 years (including boundary values), male or female.\n4. At screening and baseline, the investigator rated moderate to severe submental outline protrusion due to submental fat accumulation according to the clinician-reported Submental Fat Rating Scale (CR-SMFRS), i.e., those with a score of 2 to 3 points.\n5. Sufficient submental fat to allow for safe subcutaneous fat layer injections (at least 25 injections can be completed), as judged by the investigator.\n6. Stable body weight for at least 6 months prior to Screening.\n7. Vital sign examinations, physical examinations, clinical laboratory examinations (blood routine, urine routine, blood biochemistry, infectious disease screening, coagulation function, pregnancy test (for females), drug screening, etc.), and 12-lead electrocardiogram examinations, with the results showing no abnormalities or having abnormalities but judged by the researcher as being of no clinical significance.\n8. Subjects had no pregnancy plans and voluntarily take effective contraceptive measures during the screening period and within 6 months after the last dose, and have no sperm or egg donation plans.\n\nExclusion Criteria:\n\n1. Subjects who have previously undergone surgical operations, liposuction treatments in the submental area that may affect the implementation and\u002For evaluation of the study, or have been injected with lipolytic drugs similar to the study drugs (for example, phosphatidylcholine, etc.).\n2. Subjects who have had previous allergic reactions to deoxycholic acid or other components of the investigational drug.\n3. History of hypersensitivity to topical or local anesthetics (e.g., lidocaine, benzocaine, procaine, etc.).\n4. Subjects with a history of prior surgery in the chin or neck region; or significant submental scarring, infection, cancerous or precancerous lesions, and\u002For unhealed wounds, mandibular retrusion (a mandibular retrusion malocclusion caused by mandibular hypoplasia or congenital absence of lower anterior teeth and lateral pterygoid insufficiency) that could affect the evaluation results as assessed by the investigator.\n5. Subjects with chin and neck skin diseases, or with a keloid-forming tendency (with a previous tendency of scar hyperplasia or keloid), which may affect the efficacy evaluation or subject safety as judged by the investigator.\n6. Subjects who have received previous lipolytic therapy with poor efficacy or serious adverse reactions.\n7. Platissimus muscle protrusion at rest, as judged by the investigator, impacts assessment of submental fat status.\n8. Including but not limited to Madelung's disease (benign symmetric lipomatosis) which leads to an increase in local fat in the neck area and needs to be excluded as judged by the investigator.\n9. Body Mass Index (BMI) less than 17 or greater than 40 kg\u002Fm2 (excluding borderline) at screening.\n10. Current or past dysphagia.\n11. Subjects with very severe laxity of the submental skin as judged by the investigator.\n12. Enlargement of the submental area was found to be due to other causes rather than local excessive submental fat accumulation.\n13. Subjects who have used drugs that can prolong the clotting time (for example, aspirin, non-steroidal anti-inflammatory drugs, clopidogrel, warfarin, etc.) within 2 weeks before screening, or who need to take any drugs with anticoagulant functions (including but not limited to warfarin, heparin) during the trial.\n14. Subjects who have used topical drugs (such as glucocorticoids, tretinoin ointment) on the submental skin within 1 month before screening, or who are expected to need to use these drugs on the submental area during the research process (until 12 weeks after the completion of the last injection).\n15. Subjects who have donated blood (including blood components) or suffered from massive blood loss (≥200 mL) within 3 months before screening.\n16. Subjects who smoked more than 5 cigarettes per day within 3 months before screening, or who were unable to stop using any tobacco products during the PK blood sampling period.\n17. Subjects who consumed more than 14 units of alcohol per week within 3 months before screening (1 unit of alcohol is approximately equivalent to 360 mL of beer, 45 mL of spirits with an alcohol content of 40%, or 150 mL of wine), or who were unable to abstain from alcohol during the PK blood sampling period.\n18. Subjects who consumed any food or beverage containing caffeine or that can produce caffeine after metabolism (such as coffee, tea, chocolate) within 48 hours before drug administration; or those who did not agree to refrain from consuming such food or beverage during the PK blood sampling period.\n19. Subjects who participated in any other drug clinical trials and received drug treatment within 3 months before screening.\n20. Subjects with a history of drug abuse within 6 months before screening or who used drugs within 3 months before screening.\n21. Subjects who received ultrasonic scalpel, radiofrequency, laser surgery, chemical peeling or skin fillers (such as hyaluronic acid) treatment for the neck or submental area within 12 months before screening, or who received botulinum toxin injection treatment for the neck or submental area within 6 months before screening; or who received non-invasive skin tightening treatment within 6 months before screening.\n22. According to the researcher's judgment, the dissolution of submental fat would cause submental skin laxity or have other anatomical features (for example, protrusion of the subplatysmal fat, skin laxity in the neck or chin area, protrusion of the platysma band), resulting in an unacceptable cosmetic effect.\n23. At the time of enrollment screening, the results of coagulation function tests, including prothrombin time (PT) and activated partial thromboplastin time (APTT), showed bleeding abnormalities of clinical significance.\n24. Subjects who cannot tolerate venipuncture, have a history of fainting due to needles or blood, or have significant abnormal clinical manifestations.\n25. Subjects with diseases that require exclusion due to significant abnormal clinical manifestations, including but not limited to diseases of the nervous system, cardiovascular system, blood and lymphatic system, immune system, kidneys, liver, gastrointestinal tract, respiratory system, metabolism, skeletal system and other systems.\n26. Subjects suffering from any diseases that may interfere with the safety assessment of the trial or affect the normal conduct of the clinical trial by the subjects or the signing of the informed consent form.\n27. Subjects whose participation in the trial may increase their risks or who may have other severe, acute or chronic diseases that may interfere with the interpretation of the trial results and are judged by the researcher as not suitable for participating in the clinical trial.\n28. Subjects who plan to undergo any surgeries or take any drugs that may lead to significant changes in body weight (≥10%) during the study period (for example, systemic corticosteroids, weight-loss drugs, bariatric surgeries).\n29. Subjects with infectious diseases before screening, such as syphilis, AIDS, hepatitis B, etc.\n30. Female subjects with potential fertility who are pregnant, breastfeeding, planning to become pregnant or not taking reliable contraceptive measures, and who are unwilling to adopt reliable contraceptive methods (for example: transdermal patches, intrauterine devices\u002Fsystems (IUD\u002FIUS), oral\u002Fimplanted or injected contraceptives, abstinence and vasectomy of their spouses) during the participation in the trial.\n31. Subjects with other comorbidities that may interfere with the research assessment only as judged by the researcher, or subjects who are considered by the researcher as facing greater risks due to participation in the study.\n32. Subjects judged by the researcher as not suitable for participating in this trial for other reasons.","65 Years",{"count":94,"type":22},30,[25],"The main purpose of this study is to evaluate the safety of HY-2003 in subjects with moderate to severe submental fat accumulation at different doses and dosing frequencies in comparison with the positive control and placebo. The secondary objectives include: Evaluating the pharmacokinetic characteristics of HY-2003 after a single administration in humans and obtaining preliminary pharmacokinetic parameters; Evaluating the efficacy of HY-2003 under different doses and dosing frequencies, compared with the positive control and placebo, in the treatment of subjects with moderate to severe submental fat accumulation.",[98],"Moderate or Severe Submental Fullness",{"date":59,"type":33},{"date":101,"type":33},"2024-12-26",{"date":103,"type":22},"2027-05-31",{"name":39,"class":40},2,{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":23,"phases":115,"briefSummary":116,"conditions":117,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},"100534786","phase-1-phase-12-study-of-hyp-2090ptsa-in-patients-with-advanced-solid-tumors-harboring-kras-mutation-100534786","NCT06243354","Phase 1\u002F2 Study of HYP-2090PTSA in Patients With Advanced Solid Tumors Harboring KRAS Mutation","An Open-label, Multi-center, Multi-cohort, Phase 1\u002F2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HYP-2090PTSA in Patients With Advanced Solidt Tumors Harboring KRAS Mutation","Inclusion Criteria:\n\n* A written informed consent should be signed by a subject or his\u002Fher legal representative before any study-related procedures are performed;\n* 18 Years and older;\n* Subjects with histologically or cytologically confirmed locally advanced or metastatic advanced solid tumors;\n* Subjects must have at least one measurable lesion as defined by RECIST v1.1;\n* Eastern Cooperative Oncology Group(ECOG) performance status 0-1;\n* Expected survival ≥ 3 months;\n* Patients are willing to use a highly effective method of birth control during the study, and for at least 180 days after the last dose of study medication.\n\nExclusion Criteria:\n\n* Patients who have received major surgical or interventional treatment within 4 weeks prior to the first dose, with the exception of tumor biopsy, puncture, etc. Patients who have received anti-tumor therapy (radiotherapy, immunologic therapy or biological therapy) within 4 weeks, prior to the first dose, or received small molecular targeted therapy, chemotherapy within 2 weeks, or received palliative radiotherapy for bone metastases within 2 weeks, or received nitrosoureas or mitomycin C within 6 weeks;\n* Patients who have received live vaccines within 4 weeks prior to the first dose;\n* Patients who have previously participated in clinical trials of other drugs within 4 weeks before the first dose;\n* Patients with a history of central nervous system disease within 12 months prior to enrollment, such as seizures, cerebral vascular embolism\u002Fhemorrhage, paralysis, aphasia, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychiatric disease, or any autoimmune disease with involvement of the central nervous system;\n* Presence of severe pulmonary diseases such as pulmonary embolism, interstitial lung disease at screening;\n* Patients who have previously received allogeneic tissue\u002Fsolid organ transplantation;\n* Patients with active infection;\n* Patients who are positive for human immunodeficiency virus (HIV) (HIV1\u002F2 antibody), positive treponema pallidum antibody (positive treponema pallidum antibody is required to undergo a confirmatory test, and those with negative confirmatory test can be enrolled), active chronic hepatitis B (HBsAg positive and HBV DNA \\> 500 IU\u002FmL) or active hepatitis C (HCV antibody positive and HCV-RNA \\> lower limit of detection by the research center);\n* Female subjects who are lactating or have a positive blood\u002Furine pregnancy result during the screening period;\n* Any other condition of the subject (e.g., mental, geographical, or medical condition) that does not allow him or her to comply with the study and follow-up procedures, or other conditions that, in the judgment of the investigator, the subject is not suitable for inclusion in this study.",{"count":114,"type":22},257,[25,53],"This is a multicenter, open-label phase 1\u002F2 study consisting of two parts: dose escalation phase and dose expansion phase. The objective of the dose escalation phase is to evaluate the safety, tolerability and pharmacokinetics of HYP-2090PTSA in patients with advanced solid tumors harboring KRAS mutation and to determine the RP2D. In the dose expansion phase, preliminary efficacy and safety at the RP2D will be further explored in patients with specific cancer harboring KRAS p.G12C mutation.",[118,119,120],"Safety","Tolerability","Efficacy","2026-01-27",{"date":123,"type":33},"2026-01-29",{"date":125,"type":33},"2024-02-04",{"date":127,"type":22},"2026-12",{"name":39,"class":40},6,{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":4,"eligibilityCriteria":136,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":137,"enrollmentInfo":138,"targetDuration":4,"studyType":23,"phases":140,"briefSummary":141,"conditions":142,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":41},"100565213","phase-1-phase-12-clinical-study-of-hy07121-powder-for-solution-for-infusion-in-patients-with-advanced-solid-tumors-100565213","NCT06639256","Phase 1\u002F2 Clinical Study of HY07121 Powder for Solution for Infusion in Patients With Advanced Solid Tumors","An Open-label, Multiple-center, Phase 1\u002F2 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of HY07121 Powder for Solution for Infusion in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n* Written informed consent;\n* ≥18 years old and ≤80 years old, gender: male or female;\n* Histologically or cytologically confirmed unresectable advanced\u002Fmetastatic solid tumor that has relapsed or progressed on or after standard systemic treatments, or refused the standard treatment, or for which no standard treatment is available;\n* Presence of at least one measurable lesion according to Response Evaluation Criteria in Solid Tumours (RECIST) Version 1.1;\n* Eastern Cooperative Oncology Group (ECOG) performance status score is 0 or 1;\n* Life expectancy ≥3 months;\n* Participant must have adequate main organ function;\n* Fertile female patients must have a negative serological pregnancy test within 7 days before the first dosing and be willing to use effective birth control\u002Fcontraception to prevent pregnancy during the study period up to 6 months after the last dosing of the study. Male patients must agree to have no sperm donation plans and to use effective contraceptive methods during the study period until 6 months after the last dose of the study. Postmenopausal women must have amenorrhea for at least 12 months before they are considered infertile.\n\nExclusion Criteria:\n\n* Within the defined washout periods for prior anti-cancer treatments;\n* Participant is currently participating or has participated in a study of an investigational agent or using an investigational device within 4 weeks of first dose of HY07121.\n* Any other malignancy within 2 years prior to the first dose of the study treatment except for localized cancers that are considered to have been cured and in the opinion of the Investigator present a low risk for recurrence.\n* Participant has not recovered (i.e., to Grade 1 or to baseline) from previous anticancer therapy-induced Adverse Events (AEs).\n* Participants with a history of recently (within previous 2 years of the first dose of the study treatment) active diverticulitis or symptomatic peptic ulcer disease;\n* Major surgery within 4 weeks of receiving the first dose of study treatment;\n* Participant has Symptomatic Central Nervous System (CNS) metastases, or CNS metastases requiring CNS-directed local therapy (such as radiotherapy or surgery) or corticosteroids therapy within 4 weeks of first dose of study treatment;\n* Participants with untreated or under treatment for tuberculosis, including but not limited to tuberculosis; Patients who have received standardized anti-tuberculosis treatment and have been confirmed cured by the researchers can be included;\n* Participants with clinically significant cardiovascular diseases, in the past 6 months prior to the first dose of the study treatment; symptomatic coronary heart disease requiring drug treatment; arrhythmia requiring drug treatment; or uncontrolled hypertension;\n* Known Human Immunodeficiency Virus (HIV) infection or known Acquired Immunodeficiency Syndrome (AIDS);\n* Active or chronic hepatitis B or hepatitis C infection; treponema pallidum antibody positive, and confirmed positive test;\n* Active known or suspected autoimmune disease.\n* History of non-infectious pneumonitis that has required a course of oral or intravenous steroids to assist with recovery, or interstitial lung disease or severe obstructive pulmonary disease;\n* History of severe allergy;\n* History of allogeneic organ transplantation or graft-versus-host disease;\n* Have received live\u002Fattenuated vaccines and mRNA vaccines within 4 weeks prior to screening or plan to receive live\u002Fattenuated vaccines and mRNA vaccines during the study period;\n* Any active infection requires systemic treatment via intravenous infusion within 4 weeks prior to the first dose of study treatment;\n* Known psychiatric disorder or drug abuse that would interfere the trial requirements;\n* Participant with uncontrolled pleural effusion, pericardial effusion or peritoneal effusion or need drainage;\n* In addition to the tumors present at the time of entry into the study, other active malignancies were present within 3 years prior to the first dose (not excluding locally cured tumors, such as skin basal cell carcinoma, superficial bladder cancer or carcinoma in situ of the breast, etc.);\n* Participants considered unsuitable for participation in this study by the investigators.","80 Years",{"count":139,"type":22},258,[25,53],"This is a multi-center, open-label, phase 1\u002F2 study to evaluate the safety, efficacy, and pharmacokinetic (PK)\u002Fpharmacodynamic (PD) characteristics of HY07121 in participants with advanced solid tumors.",[118,119,120],"2026-01-26",{"date":145,"type":33},"2026-01-28",{"date":147,"type":33},"2024-10-24",{"date":149,"type":22},"2026-10",{"name":39,"class":40},{"id":152,"slug":153,"hasResults":11,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":4,"eligibilityCriteria":157,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":137,"enrollmentInfo":158,"targetDuration":4,"studyType":23,"phases":160,"briefSummary":161,"conditions":162,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":41},"100570856","phase-1-a-phase-iii-study-of-hyp-6589-monotherapy-in-treating-advanced-solid-tumors-and-in-combination-with-tyrosine-kinase-inhibitors-in-treating-patients-with-advanced-nsclc-positive-for-driver-genes-100570856","NCT06712680","A Phase I\u002FII Study of HYP-6589 Monotherapy in Treating Advanced Solid Tumors and in Combination With Tyrosine Kinase Inhibitors in Treating Patients With Advanced NSCLC Positive for Driver Genes","A Phase I\u002FII , Open-label, Multi-center, Multi-cohort Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of HYP-6589 Monotherapy in Advanced Solid Tumors and Combination With Tyrosine Kinase Inhibitors in Patients With Advanced NSCLC With Target-driven Gene Positivity","Inclusion Criteria:\n\n* Voluntarily sign an informed consent form, understand the study and be willing and able to follow and complete all trial procedures;\n* ≥18 years old and ≤80 years old, gender: male or female;\n* Histological or cytological confirmation of unresectable and\u002For metastatic advanced solid tumors;\n* At least one measurable lesion (according to RECIST 1.1 version);\n* Eastern Cooperative Oncology Group (ECOG) performance status score is 0 or 1;\n* Life expectancy ≥3 months;\n* Participant must have adequate main organ function;\n* Fertile female patients must have a negative serological pregnancy test within 7 days before the first dosing and be willing to use effective birth control\u002Fcontraception to prevent pregnancy during the study period up to 6 months after the last dosing of the study. Male patients must agree to have no sperm donation plans and to use effective contraceptive methods during the study period until 6 months after the last dose of the study. Postmenopausal women must have amenorrhea for at least 12 months before they are considered infertile.\n\nExclusion Criteria:\n\n* Participants who have received other investigational drugs or participated in interventional medical device studies within 4 weeks prior to the first administration of the study drug;\n* Participants who have received (attenuated) live vaccines within 4 weeks prior to the first administration of the study drug;\n* Participants who have undergone major organ surgery (excluding biopsy) within 4 weeks prior to the first administration of the study drug or have experienced significant trauma, or who require elective major organ surgery (excluding biopsy) during the study period;\n* Participants who, based on computerized tomography (CT) or magnetic resonance imaging (MRI) examinations conducted during the screening period and before radiological assessment, have uncontrolled, unstable, or active central nervous system (CNS) metastases;\n* Participants with clinically uncontrollable hypertension (defined in this protocol as having a systolic blood pressure \\> 150 mmHg and\u002For a diastolic blood pressure \\> 100 mmHg despite antihypertensive treatment, and which is considered clinically significant by the investigator);\n* Participants who have received allogenic tissue\u002Forgan transplants in the past;\n* Participants with active infections deemed inappropriate for entry into the study by the investigator;\n* Participants with uncontrolled third-space effusion requiring clinical intervention;\n* Participants with a history of drug abuse or medical, psychological, or social conditions that may interfere with study participation or impair the assessment of study outcomes;\n* Participants with known gastrointestinal (GI) dysfunction or GI diseases that are likely to significantly affect the absorption or metabolism of oral medications (e.g., dysphagia, active upper gastrointestinal ulcer, intestinal obstruction, nausea, vomiting, and diarrhea of grade 3 or higher that persist despite optimal supportive care within 3 days);\n* Participant whose toxicities from previous anti-cancer therapy have not resolved, defined as toxicity (hair loss excluded) that has not resolved to grade ≤1 (CTCAE 5.0 version, peripheral neuropathy, ≤grade 2; exclusion criteria specified);\n* Female participants who are breastfeeding or have positive urine or blood pregnancy test results during the screening period; female participants who have a planned pregnancy, sperm donation, or egg donation during the study period or within 6 months after the last study drug administration;\n* Known history of hypersensitivity to any of the components of the test formulation.\n* Participants who have had other malignancies within the past 5 years, excluding cured cervical carcinoma in situ, basal cell carcinoma of the skin or squamous cell carcinoma of the skin;",{"count":159,"type":22},115,[25,53],"This is a multi-center , open-label, phase 1\u002F2 study to evaluate the safety, efficacy, and pharmacokinetic (PK) characteristics of HYP-6589 in monotherapy in advanced solid tumors and combination with tyrosine kinase inhibitors in patients with advanced NSCLC with target-driven gene positivity.",[56],"2025-12-21",{"date":165,"type":33},"2025-12-23",{"date":167,"type":33},"2024-11-27",{"date":169,"type":22},"2028-04-10",{"name":39,"class":40},{"id":172,"slug":173,"hasResults":11,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":4,"eligibilityCriteria":177,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":49,"enrollmentInfo":178,"targetDuration":4,"studyType":23,"phases":180,"briefSummary":181,"conditions":182,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":41},"100599348","phase-1-a-phase-iii-study-of-hy05350-in-mesothelinmsln-positive-advanced-solid-tumors-100599348","NCT07083323","A Phase I\u002FII Study of HY05350 in Mesothelin(MSLN)-Positive Advanced Solid Tumors","A Multicenter, Open-label Phase I\u002FII Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Clinical Efficacy of HY05350 for Injection in Patients With MSLN-positive Advanced Solid Tumors","Inclusion Criteria:\n\n1. Aged ≥18 years and ≤75 years at the time of signing the informed consent form, regardless of gender.\n2. Investigator-assessed expected survival period ≥3 months.\n3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.\n4. Patients with cytologically or pathologically confirmed advanced solid tumors who have failed standard treatment.\n5. Subjects enrolled in the dose escalation stage must have evaluable tumor lesions, and subjects enrolled in the dose expansion stage must have at least one measurable tumor lesion (based on RECIST 1.1).\n6. Participant must have adequate main organ function.\n7. Agree to provide archived pathological tissues or fresh biopsy tumor tissues for detection of related markers such as MSLN and Programmed cell death ligand 1 (PD-L1) expression levels, and MSLN expression is positive.\n8. Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days before the first drug administration, and be willing to use effective contraceptive methods to prevent pregnancy and have no plans to donate eggs during the study period and for 6 months after the last drug administration. Male subjects must agree to have no plans to donate sperm and use effective contraceptive methods during the study period and for 6 months after the last drug administration. Postmenopausal women must have been amenorrheic for at least 12 months to be considered non-childbearing.\n\nExclusion Criteria:\n\n1. Received radiotherapy, chemotherapy, endocrine therapy, biological therapy, immunotherapy and other anti-tumor therapies within 4 weeks before the first drug administration.\n2. Received other investigational drugs or participated in interventional medical device studies within 4 weeks before the first drug administration.\n3. Had received or planned to receive live\u002Fattenuated vaccines or mRNA vaccines within 4 weeks before screening.\n4. Pregnant or lactating women.\n5. Subjects with adverse events caused by previous anti-tumor therapy that remained \\> Grade 1 (based on CTCAE 5.0) before the first drug administration.\n6. Subjects with a history of ≥ Grade 3 immune-related adverse events or who discontinued immunotherapy due to irAE of any grade.\n7. Subjects with primary central nervous system (CNS) tumors, symptomatic CNS metastases, meningeal metastases, or a history of epilepsy are excluded.\n8. Subjects who underwent major surgery on vital organs (excluding biopsy) within 4 weeks before the first drug administration, experienced significant trauma, or require major elective surgery during the trial.\n9. Subjects with a history of tissue or organ transplantation.\n10. Subjects who had severe infections within 4 weeks before the first drug administration.\n11. Positive human immunodeficiency virus test.\n12. Active hepatitis B, untreated chronic hepatitis B, or chronic hepatitis B that is treated but uncontrolled.\n13. Subjects with active Hepatitis C virus(HCV) infection;\n14. Positive treponema pallidum antibody and confirmed positive by diagnostic test;\n15. Subjects with untreated or ongoing tuberculosis.\n16. Known severe allergic history, or known allergic reactions to macromolecular protein preparations\u002Fantibodies or any component of the investigational drug.\n17. History of active autoimmune diseases or a history of autoimmune diseases with potential for recurrence.\n18. Subjects who received systemic glucocorticoids or other immunosuppressants within 14 days before the first drug administration.\n19. History of non-infectious pneumonia requiring glucocorticoid treatment or current interstitial lung disease.\n20. History of severe cardiovascular and cerebrovascular diseases.\n21. Subjects with thrombosis or bleeding risk.\n22. Known history of psychoactive substance abuse or drug use that is considered to affect study compliance.\n23. Except for the tumor enrolled in the study, subjects with other active malignant tumors within 1 year before the first drug administration.\n24. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring drainage.\n25. Subjects deemed unsuitable for participation by the investigator.",{"count":179,"type":22},262,[25,53],"This is a multicenter, open-label Phase I\u002FII clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary clinical efficacy of HY05350 for injection in patients with MSLN-positive advanced solid tumors.",[183],"Advanced Solid Tumor","2025-11-24",{"date":186,"type":33},"2025-11-25",{"date":188,"type":33},"2025-07-22",{"date":190,"type":22},"2028-03-31",{"name":39,"class":40},""]