[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100567925":3},{"organization":4,"armGroups":7,"interventions":35,"overallOfficials":46,"centralContacts":47,"locations":53,"responsibleParty":72,"collaborators":46,"id":74,"slug":46,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":46,"eligibilityCriteria":79,"healthyVolunteers":80,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":46,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":46,"overallStatus":56,"whyStopped":46,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.","INDUSTRY",[8,15,19,23,27,31],{"label":9,"type":10,"description":11,"interventionNames":12},"626 Group S1 for subcutaneous injection","EXPERIMENTAL","dose level 1 of 626",[13,14],"Drug: 626","Drug: Placebo",{"label":16,"type":10,"description":17,"interventionNames":18},"626 Group S2 for subcutaneous injection","dose level 2 of 626",[13,14],{"label":20,"type":10,"description":21,"interventionNames":22},"626 Group S3 for subcutaneous injection","dose level 3 of 626",[13,14],{"label":24,"type":10,"description":25,"interventionNames":26},"626 Group S4 for subcutaneous injection","dose level 4 of 626",[13,14],{"label":28,"type":10,"description":29,"interventionNames":30},"626 Group S5 for subcutaneous injection","dose level 5 of 626",[13,14],{"label":32,"type":10,"description":33,"interventionNames":34},"626 Group S6 for subcutaneous injection","dose level 6 of 626",[13,14],[36,43],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"DRUG","626","Single subcutaneous injection",[9,16,20,24,28,32],[42],"SSGJ-626",{"type":37,"name":44,"description":39,"armGroupLabels":45,"otherNames":46},"Placebo",[9,16,20,24,28,32],null,[48],{"name":49,"role":50,"phone":51,"phoneExt":46,"email":52},"Qinghong Zhou","CONTACT","+86 18911301578","zhouqinghong@3sbio.com",[54],{"facility":55,"status":56,"city":57,"state":46,"zip":58,"country":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"Shanghai General Hospital","RECRUITING","Shanghai","200080","China",{"type":61,"coordinates":62},"Point",[63,64],121.45806,31.22222,{"lat":64,"lon":63},[67,71],{"name":68,"role":50,"phone":69,"phoneExt":46,"email":70},"Xueying Ding, PhD","+86 13761642319","dingxueying@126.com",{"name":68,"role":50,"phone":46,"phoneExt":46,"email":46},{"type":73,"investigatorFullName":46,"investigatorTitle":46,"investigatorAffiliation":46,"oldNameTitle":46,"oldOrganization":46},"SPONSOR","100567925",false,"NCT06674525","Evaluation of 626 in Healthy Adult Subjects","A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of SSGJ-626 in Healthy Adult Subjects","Inclusion Criteria:\n\n* Able to understand protocol requirements and sign a written ICF.\n* Male or female subjects aged 18-45 years when signing the ICF.\n* Male subjects with body weight ≥ 50 kg, and female subjects with body weight ≥ 45 kg. Subjects with BMI between 18 and 28 kg\u002Fm2.\n* Subjects whose test results are normal, or abnormal without clinical significance as determined by the investigator.\n* Female subjects with childbearing potential and male subjects (and their female partners) must agree to take highly effective contraceptive measures.\n\nExclusion Criteria:\n\n* History of severe allergy, or with a history of allergy to the study treatment or related excipients.\n* With any clinically significant diseases prior to the screening visit.\n* Subjects with positive test results for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibody, anti-human immunodeficiency virus (HIV) antibody.\n* History of of significant alcohol abuse.\n* History of significant drug abuse.\n* Subjects who have positive result for urine nicotine test at screening.\n* Pregnant, or nursing females.",true,"ALL","18 Years","45 Years",{"count":85,"type":86},50,"ESTIMATED","INTERVENTIONAL",[89],"PHASE1","This is a randomized, double-blind, placebo-controlled, single ascending dose phase I clinical study to evaluate the safety, tolerability, PK and immunogenicity of SSGJ-626 in healthy adult subjects after single subcutaneous injection.",[92],"Healthy Subjects (HS)","2024-12-05",{"date":95,"type":96},"2024-12-10","ACTUAL",{"date":98,"type":96},"2024-12-02",{"date":100,"type":86},"2025-10",{"name":5,"class":6},1]