[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100597949":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":28,"locations":11,"responsibleParty":34,"collaborators":11,"id":36,"slug":37,"hasResults":38,"nctId":39,"briefTitle":40,"officialTitle":41,"acronym":11,"eligibilityCriteria":42,"healthyVolunteers":43,"sex":44,"minAge":45,"maxAge":46,"enrollmentInfo":47,"targetDuration":11,"studyType":50,"phases":51,"briefSummary":53,"conditions":54,"keywords":11,"overallStatus":56,"whyStopped":11,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":11},{"fullName":5,"class":6},"Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"627","EXPERIMENTAL",null,[13,14],"Biological: 627","Other: Placebo",{"label":16,"type":17,"description":11,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR",[13,14],[20,24],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":11},"BIOLOGICAL","subcutaneous injection",[9,16],{"type":25,"name":16,"description":26,"armGroupLabels":27,"otherNames":11},"OTHER","Single subcutaneous injection",[9,16],[29],{"name":30,"role":31,"phone":32,"phoneExt":11,"email":33},"zhou","CONTACT","021-8029 7777","zhouqinghong@3sbio.com",{"type":35,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100597949","phase-1-evaluation-of-627-in-healthy-adult-subjects-100597949",false,"NCT07065136","Evaluation of 627 in Healthy Adult Subjects","A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose and Multiple Ascending Dose Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of SSGJ-627 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* 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":48,"type":49},108,"ESTIMATED","INTERVENTIONAL",[52],"PHASE1","This is a randomized, double-blind, placebo-controlled, single ascending dose and multiple ascending dose phase I clinical study to evaluate the safety, tolerability, PK and immunogenicity of SSGJ-627 in healthy adult subjects after single subcutaneous injection.",[55],"Healthy Subjects (HS)","NOT_YET_RECRUITING","2025-07-14",{"date":59,"type":60},"2025-07-15","ACTUAL",{"date":62,"type":49},"2025-07-20",{"date":64,"type":49},"2026-09-18",{"name":5,"class":6}]