[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646110":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":26,"locations":32,"responsibleParty":50,"collaborators":11,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":11,"eligibilityCriteria":58,"healthyVolunteers":59,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":11,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":11,"overallStatus":35,"whyStopped":11,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"SSGJ-716","EXPERIMENTAL",null,[13],"Drug: SSGJ-716",{"label":15,"type":16,"description":11,"interventionNames":17},"Placebo","PLACEBO_COMPARATOR",[18],"Drug: Placebo",[20,24],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":11},"DRUG","Single and multiple subcutaneous injection",[9],{"type":21,"name":15,"description":22,"armGroupLabels":25,"otherNames":11},[15],[27],{"name":28,"role":29,"phone":30,"phoneExt":11,"email":31},"Qinghong Zhou","CONTACT","+86 189113015","zhouqinghong@3sbio.com",[33],{"facility":34,"status":35,"city":36,"state":11,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Huashan Hospital, Fudan University","RECRUITING","Shanghai","200040","China","CN",{"type":41,"coordinates":42},"Point",[43,44],121.45806,31.22222,{"lat":44,"lon":43},[47],{"name":48,"role":49,"phone":11,"phoneExt":11,"email":11},"Jing Zhang","PRINCIPAL_INVESTIGATOR",{"type":51,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100646110","phase-1-a-phase-i-study-of-ssgj-716-in-healthy-adults-and-participants-with-moderate-to-severe-atopic-dermatitis-100646110",false,"NCT07693738","A Phase I Study of SSGJ-716 in Healthy Adults and Participants With Moderate-to-Severe Atopic Dermatitis","A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Characteristics of SSGJ-716 Injection Administered Subcutaneously in Healthy Chinese Adults and Participants With Moderate-to-Severe Atopic Dermatitis","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. 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. Pregnant, or nursing females.",true,"ALL","18 Years","45 Years",{"count":64,"type":65},96,"ESTIMATED","INTERVENTIONAL",[68],"PHASE1","The purpose of this Phase 1 study is to evaluate the safety and tolerability of a new investigational drug called SSGJ-716 in healthy adults and in participants with moderate-to-severe atopic dermatitis (AD).\n\nThe study has two parts. The first part (Single Ascending Dose, SAD) will enroll healthy adults.The second part (Multiple Ascending Dose, MAD) will enroll participants with moderate-to-severe AD.",[71],"AD","2026-07-08",{"date":74,"type":75},"2026-07-10","ACTUAL",{"date":77,"type":75},"2026-05-18",{"date":79,"type":65},"2028-01-29",{"name":5,"class":6},1]