[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shenzhen Kangzhe Biotechnology Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":97},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,73],{"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":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":40,"leadSponsor":42,"locationsCount":4},"100632815","phase-1-phase-1-study-of-ascending-doses-of-cms-d008-in-healthy-and-overweightobese-adults-100632815",false,"NCT07518589","Phase 1 Study of Ascending Doses of CMS-D008 in Healthy and Overweight\u002FObese Adults","A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study of Ascending Doses of CMS-D008 to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Healthy Adults and Adults Living With Overweight or Obesity","Inclusion Criteria:\n\n1. Voluntarily participate in this study, sign the informed consent form, be able to understand and comply with all requirements and restrictions of the study, and complete the study in accordance with the protocol.\n2. Male or female aged 18-56 years (inclusive)\n3. Body mass index (BMI) ≥23 kg\u002Fm2 at screening, with stable body weight in the past 4 months\n4. Glycated hemoglobin (HbA1c) \\\u003C 6.5% and fasting plasma glucose \\\u003C 7 mmol\u002FL at screening.\n5. Participants of childbearing potential (including their partners) have no plan to conceive, donate oocytes, or donate sperm from the date of signing the informed consent form until 7 months after the last study drug administration, and must comply with contraceptive requirements during this period\n\nExclusion Criteria:\n\n1. History or presence of liver disease (except fatty liver disease), allergy, cardiovascular, endocrine (except primary obesity), neuropsychiatric, digestive, respiratory, hematological, immune, or genitourinary system major diseases.\n2. History or presence of endocrine diseases that may significantly affect body weight, or obesity caused by medication use, single gene mutation, or genetic obesity syndromes.\n3. Any skin conditions that may interfere with the assessment of injection-site reactions.\n4. Use of any siRNA agent in the prior 12 months\n5. Use of glucagon-like peptide-1 (GLP-1) receptor agonists and other weight-loss medications in the past 6 months.\n6. Use of any prescription or non-prescription drugs (including Chinese herbal medicines, vitamins, minerals, and dietary supplements, etc.) within 2 weeks before dosing or at least 5 elimination half-lives, whichever is longer.\n7. Participants with clinically significant abnormalities in vital signs, physical examination, laboratory tests, 12-lead ECG, and other auxiliary examinations at screening or baseline, who are considered by the investigator to be ineligible for enrollment.",true,"ALL","18 Years","55 Years",{"count":21,"type":22},110,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","This study is a first-in-human clinical trial of CMS-D008 conducted in Chinese healthy and overweight or obese adult participants, consisting of three parts: Part-1 Single Ascending Dose (SAD) study (hereinafter referred to as Part-1 SAD study), Part-2 Multiple Ascending Dose (MAD) study (hereinafter referred to as Part-2 MAD study), and Part-3 expansion study. The study aims to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD) characteristics, and immunogenicity of single and multiple subcutaneous injections of CMS-D008 injection in Chinese healthy and overweight or obese adult participants.",[28,29],"Evaluate the Safety and Tolerability","Healthy and Overweight or Obese Participants",[31,32,33],"Phase 1 clinical study","safety","fat loss","NOT_YET_RECRUITING","2026-04-02",{"date":37,"type":38},"2026-04-08","ACTUAL",{"date":35,"type":22},{"date":41,"type":22},"2027-12-10",{"name":43,"class":44},"Shenzhen Kangzhe Biotechnology Co., Ltd.","INDUSTRY",{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":52,"targetDuration":4,"studyType":23,"phases":54,"briefSummary":55,"conditions":56,"keywords":59,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":66,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":72},"100628526","phase-1-a-phase-i-clinical-trial-to-evaluate-cms-d017-following-single-and-multiple-doses-in-healthy-participants-100628526","NCT07462780","A Phase I Clinical Trial to Evaluate CMS-D017 Following Single and Multiple Doses in Healthy Participants","A Randomized, Double-blind, Placebo-controlled, Dose-escalation Phase I Study to Evaluate the Safety, Tolerability, PK and PD Characteristics of CMS-D017 Following Single and Multiple Administrations in Healthy Participants","Inclusion Criteria:\n\n1. Voluntarily participates in this study and signs the informed consent form.\n2. Able to communicate well with the investigator and understands and complies with all requirements and restrictions of this study, and is able to complete the study in accordance with the protocol.\n3. Aged 18-55 years (inclusive, as of the day of signing the informed consent form), male or female.\n4. Body Mass Index (BMI) between 19.0 and 26.0 kg\u002Fm² (inclusive) at screening, with females weighing ≥ 45.0 kg and males weighing ≥ 50.0 kg.\n5. Participants (and their partners) with reproductive capacity must have no plans for pregnancy, egg donation, or sperm donation from the date of signing the informed consent form until 3 months after the last dose of the study drug, and must comply with contraceptive requirements (see Appendix 1), agreeing to use at least one highly effective non-hormonal contraceptive method.\n\nExclusion Criteria:\n\nAllergy History\n\n1. History of severe allergies, including food allergies, or allergy to the study drug or its components.\n\n   Medical History\u002FConditions\n2. Significant history or clinical manifestations of cardiovascular, respiratory, digestive, urogenital, hematologic, endocrine and metabolic, rheumatic, immunologic, neuropsychiatric, or musculoskeletal diseases requiring medication and\u002For other treatments (including dietary restrictions and physical therapy), as deemed unsuitable for participation in this study by the investigator.\n3. Any condition that may affect drug absorption, including but not limited to: malabsorption syndrome, inflammatory bowel disease, celiac disease, gastrectomy, cholecystectomy, bowel resection (except appendectomy).\n4. History of meningococcal infection or first-degree relatives with history of meningococcal infection.\n5. Active infection or acute disease state (e.g., fever, nausea, vomiting, or diarrhea) within 2 weeks prior to screening.\n6. Current history of tuberculosis infection; or positive tuberculosis (TB) test result. Note: If the TB test result is indeterminate, one repeat test is allowed.\n7. History of severe trauma or surgery within 8 weeks prior to screening, or planned surgery during the study period.\n8. History or current presence of the following cardiac risk factors:\n\n   Torsades de pointes or risk factors (e.g., hypokalemia, hypomagnesemia, use of drugs causing delayed cardiac repolarization) History of cardiac arrest, syncope, heart failure; myocardial infarction, angina; valvular heart disease; cardiomyopathy or family history; clinically significant arrhythmias (e.g., sick sinus syndrome, atrioventricular conduction block, Adams-Stokes syndrome, Brugada syndrome or family history, long QT syndrome, atrial flutter, atrial fibrillation, supraventricular tachycardia, ventricular tachycardia).\n\n   Prior\u002FConcomitant Treatments\n9. Participation in any other clinical study involving drugs or medical devices within 3 months prior to screening, or planned participation in such studies during this study, or within 5 half-lives of that drug (whichever is longer).\n10. Vaccination within 4 weeks prior to screening or planned vaccination during the study or within 1 month after last dose (participants vaccinated against meningococcal and pneumococcal infections may be included if vaccination was completed at least 2 weeks before dosing).\n11. Use of known CYP2C8 or CYP3A inducers or inhibitors, or P-gp inhibitors within 4 weeks prior to dosing (see Appendix 2).\n12. Use of any prescription or over-the-counter drugs (including herbal medicines, vitamins, minerals, and dietary supplements) within 2 weeks or at least 5 half-lives prior to dosing, whichever is longer.\n\n    Substance Use, Alcohol, Tobacco, or Nicotine, Dietary\u002FExercise Restrictions\n13. History of drug abuse within 6 months prior to screening, or positive result for any drug abuse test.\n14. Alcohol consumption exceeding 14 units per week within 3 months prior to screening (1 unit = 360 mL beer, 150 mL wine, or 45 mL spirits), or positive breath alcohol test, or inability to abstain from alcohol during the study.\n15. Average smoking of more than 5 cigarettes per day within 3 months prior to screening, or inability to stop using any tobacco products during the study.\n16. Inability to abstain from grapefruit or grapefruit-related citrus fruits or juices (e.g., pomelo) within 7 days prior to dosing and during the study.\n17. Consumption of caffeine-containing products (e.g., coffee, tea, cola, other caffeinated beverages, or chocolate) within 3 days prior to dosing, or refusal to avoid such products throughout the study.\n18. Engagement in strenuous exercise or physical activity within 3 days prior to dosing, or refusal to avoid such activities throughout the study.\n\n    Examinations and Assessments\n19. Corrected QT interval (using Fridericia's formula, QTcF = QT\u002F(RR\\^0.33)) \\> 450 msec in males or females.\n20. Abnormal findings in physical examination, vital signs, safety laboratory tests, 12-lead ECG, or other auxiliary tests (chest X-ray, abdominal ultrasound) deemed clinically significant by the investigator.\n21. Positive test results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCVAb), syphilis antibody (TPAb), or human immunodeficiency virus antibody (HIV Ab).\n\n    Other\n22. Pregnant or lactating females.\n23. Special dietary requirements or inability to comply with standardized diet.\n24. Difficulty with venous blood sampling (e.g., history of needle or blood phobia), or poor venous condition as deemed unsuitable for enrollment by the investigator.\n25. Donation or loss of ≥ 400 mL blood within 3 months prior to screening, or receipt of blood transfusion or blood products; or planned blood or blood component donation during the study.\n26. Other conditions deemed unsuitable for participation in this study by the investigator.",{"count":53,"type":22},88,[25],"This study is a first-in-human (FIH) trial of CMS-D017 conducted in healthy Chinese adult participants, consisting of two parts: Part 1-a single ascending dose (SAD) study (referred to as Part 1 SAD), and Part 2-a multiple ascending dose (MAD) study (referred to as Part 2 MAD). The study aims to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) characteristics of CMS-D017 capsules following single and multiple oral administrations in healthy Chinese adult participants.\n\nBoth parts of the study are designed as randomized, double-blind, placebo-controlled, sequential cohort trials. Part 1 SAD plans to include 6 dose cohorts, with 8 participants per cohort (6 receiving CMS-D017 and 2 receiving placebo), for a total of 48 participants. Part 2 MAD plans to include 4 dose cohorts, with 10 participants per cohort (8 receiving CMS-D017 and 2 receiving placebo), for a total of 40 participants.",[57,58],"Paroxysmal Nocturnal Hemoglobinuria, PNH","Complement-mediated Kidney Disease",[60,61,62,63,64],"CMS-D017","Phase I trial in healthy participants","single and multiple ascending dose studies","pharmacokinetics","pharmacodynamics","RECRUITING",{"date":37,"type":38},{"date":68,"type":38},"2026-03-05",{"date":70,"type":22},"2026-12",{"name":43,"class":44},1,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":80,"minAge":18,"maxAge":81,"enrollmentInfo":82,"targetDuration":4,"studyType":23,"phases":84,"briefSummary":86,"conditions":87,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":72},"100623879","phase-2-phase-ii-study-of-cms-d002-capsule-for-uterine-fibroids-with-menorrhagia-100623879","NCT07402369","Phase II Study of CMS-D002 Capsule for Uterine Fibroids With Menorrhagia","A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Phase II Clinical Study to Explore the Efficacy and Safety of Different Doses of CMS-D002 Capsule in Participants With Uterine Fibroids Associated With Menorrhagia","Inclusion Criteria:\n\n* 1.Non-menopausal females aged 18-50 years.\n* 2\\. Body Mass Index (BMI) ≥ 18 kg\u002Fm².\n* 3\\. Participant was diagnosed with uterine fibroids by ultrasound at the time of screening, and has one or more fibroids with a diameter of at least 2 cm (longest diameter).\n* 4\\. Participant's menstrual cycle was ≥ 21 days and ≤ 35 days for the three consecutive months prior to screening, and the menstrual period was ≤ 14 days.\n* 5\\. Menorrhagia due to uterine fibroids.\n* 6\\. Agrees to use the contraceptive method specified in the protocol throughout the entire study period (from signing the informed consent form to 6 months after administration of the investigational drug).\n\nExclusion Criteria:\n\n* 1\\. Pregnant or breastfeeding female\n* 2\\. History of childbirth within 6 months prior to screening\n* 3\\. Excessive menstrual bleeding due to other causes or unknown reasons\n* 4\\. Suffering from a severe coagulation disorder (e.g., hemophilia or von Willebrand disease)\n* 5\\. Underwent myomectomy, endometrial ablation, uterine artery embolization, or magnetic resonance-guided focused ultrasound (MRgFUS)\u002Fhigh-intensity focused ultrasound (HIFUS) ablation within 6 months prior to screening\n* 6\\. Underwent endometrial ablation within one year prior to screening\n* 7\\. Severe infection, severe trauma, or major surgery within the 6 months prior to screening.\n* 8\\. History of malignant tumors within the 5 years prior to screening (excluding cured skin cancer, basal cell carcinoma, and other localized malignant tumors).\n* 9\\. Current or past (within 1 year) history of alcohol or drug abuse (including analgesic abuse).\n* 10\\. Currently participating in other research projects and having used the investigational drug\u002Ftreatment within 12 weeks prior to administration.","FEMALE","50 Years",{"count":83,"type":22},120,[85],"PHASE2","Objective This study evaluates whether CMS-D002 capsules are effective in treating menorrhagia in participants with uterine fibroids associated with menorrhagia. The primary outcome is the percentage of participants who achieve menstrual blood loss \\\u003C80 mL and a reduction of ≥50% from baseline.\n\nStudy Design This is a placebo-controlled trial. Participants will be randomized to receive either CMS-D002 capsules or a matching placebo for 12 weeks.\n\nParticipant Responsibilities Take one CMS-D002 capsule or placebo daily for 12 weeks. Complete an electronic patient diary daily throughout the study to record menstrual bleeding and other symptoms.",[88],"Uterine Fibroids With Menorrhagia","2026-03-09",{"date":91,"type":38},"2026-03-11",{"date":93,"type":38},"2026-02-19",{"date":95,"type":22},"2027-12-31",{"name":43,"class":44},""]