[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100596090":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":34,"locations":40,"responsibleParty":60,"collaborators":24,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":24,"eligibilityCriteria":68,"healthyVolunteers":69,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":24,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":43,"whyStopped":24,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Changchun GeneScience Pharmaceutical Co., Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"GenSci120","EXPERIMENTAL","Multiple ascending doses of GenSci120 administered subcutaneously (SC).",[13],"Drug: GenSci120",{"label":15,"type":10,"description":16,"interventionNames":17},"Placebo","Multiple ascending doses of placebo administered subcutaneously (SC).",[18],"Drug: Placebo",[20,25],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","a total of 3 doses of the investigational medicinal product (IMP) SC every four weeks (Q4W) at the planned dose level",[9],null,{"type":21,"name":15,"description":22,"armGroupLabels":26,"otherNames":24},[15],[28,32],{"name":29,"affiliation":30,"role":31},"Jing Zhang, M.D.","Huashan Hospital","PRINCIPAL_INVESTIGATOR",{"name":33,"affiliation":30,"role":31},"Xiaojie Wu, M.D.",[35],{"name":36,"role":37,"phone":38,"phoneExt":24,"email":39},"Yiting Chi, Master","CONTACT","+86 13482779422","chiyiting@genscigroup.com",[41],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Huashan Hospital Affiliated to Fudan University","RECRUITING","Shanghai","Shanghai Municipality","200040","China","CN",{"type":50,"coordinates":51},"Point",[52,53],121.45806,31.22222,{"lat":53,"lon":52},[56],{"name":57,"role":37,"phone":58,"phoneExt":24,"email":59},"Wei Liu","021-52887926","383618205@qq.com",{"type":61,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100596090","phase-1-assessment-of-the-safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-multiple-subcutaneous-injections-of-gensci120-in-healthy-adult-participants-in-china-100596090",false,"NCT07040930","Assessment of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Subcutaneous Injections of GenSci120 in Healthy Adult Participants in China.","A Phase Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Subcutaneous Injections of GenSci120 in Healthy Adult Participants in China","Inclusion Criteria:\n\n1. Ages 18-55; ≥3 per gender for each cohort.\n2. BMI: 18-30; Weight: ≥50 kg (male), ≥45 kg (female).\n3. No clinically significant abnormalities in medical history, physical exam, vital signs, or lab\u002FECG\u002Fpulmonary imaging.\n4. Men\u002FWOCBP must use effective contraception throughout study; no plans to conceive; WOCBP must have negative pregnancy test and not breastfeeding. Women of non-childbearing potential: post-hysterectomy\u002Fsalpingectomy or postmenopausal (FSH \\>40 IU\u002FL).\n5. Able to provide informed consent; willing to comply with all study requirements\n\nExclusion Criteria:\n\n1. Allergy to GenSci120 or severe allergies.\n2. Injection site issues affecting evaluation.\n3. Significant medical conditions impacting study outcome.\n4. History of malignant tumors, including listed cancers.\n5. Seizure history, head injury causing unconsciousness.\n6. Psychiatric disorders impairing daily activities or cognitive issues.\n7. Severe immunodeficiency (e.g., HIV).\n8. Recent trauma, surgery, or GI issues affecting absorption.\n9. Recent severe infections or antimicrobial treatments.\n10. Live vaccines within a month prior to screening.\n11. Abnormal vital signs\u002FECG: BP extremes, QTcF \\>450ms.\n12. Positive for hepatitis B\u002FC, HIV, syphilis during screening.\n13. Positive TB test via IGRA.\n14. Recent use of immunosuppressive or targeted therapies.\n15. Medication use within 14 days prior to randomization.\n16. Participation in other clinical trials recently\u002Fcurrently.\n17. Excessive alcohol consumption (over six months).\n18. Heavy smoking, unwillingness to quit, positive nicotine tests.\n19. Positive drug screen for specific substances.\n20. Recent soft\u002Fhard drug use within specified periods.\n21. Blood donation\u002Fproduct receipt recently or poor venous access.\n22. Study staff involved in the trial.\n23. Other conditions deemed unsuitable by investigators.",true,"ALL","18 Years","55 Years",{"count":74,"type":75},30,"ESTIMATED","INTERVENTIONAL",[78],"PHASE1","This study is designed to evaluate the safety, tolerability, PK and PD of multiple subcutaneous injections of GenSci120 in a randomized, double-blind, placebo-controlled, multiple-ascending-dose phase Ib trial involving healthy adult participants.",[81],"Rheumatoid Arthritis",[83,84,85,9],"phase Ib","healthy adult","multiple subcutaneous injections","2025-08-05",{"date":88,"type":89},"2025-08-06","ACTUAL",{"date":91,"type":89},"2025-08-01",{"date":93,"type":75},"2026-09-20",{"name":5,"class":6},1]