[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Jiangsu Genscend Biopharmaceutical Co., Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":66},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"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":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100624601","phase-1-a-phase-1-clinical-study-comparing-gs101-and-dupixent-after-subcutaneous-injection-100624601",false,"NCT07411755","A Phase 1 Clinical Study Comparing GS101 and Dupixent® After Subcutaneous Injection","A Randomized, Double-blind, Parallel, Single-dose, Phase 1 Clinical Study to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity of GS101 Versus Dupixent® After Subcutaneous Injection","Inclusion Criteria:\n\n* No clinically significant abnormalities detected in physical examination, vital signs, chest X-ray (posteroanterior \\[PA\\] view), 12-lead ECG, or laboratory tests prior to investigational product administration.\n* Body mass index (BMI) between 19 and 26 kg\u002Fm² (inclusive) and body weight between 55 and 85 kg (inclusive).\n* Participants and their partner agree to use medically accepted contraceptive methods from the signing of the informed consent form until three months after dosing of the investigational product. In addition, participants have no plans to donate sperm, and their partner has no plans for pregnancy.\n\nExclusion Criteria:\n\n* History or presence at screening of neurological\u002Fpsychiatric, respiratory, cardiovascular, gastrointestinal, hematologic\u002Flymphatic, endocrine, musculoskeletal, or any other disease judged by the investigator to interfere with study assessments.\n* History of drug or food allergy (≥2 types) or history of specific allergic diseases (e.g., asthma, urticaria, eczematous dermatitis), or known hypersensitivity to monoclonal antibodies targeting the same pathway or to investigational product components.\n* Positive result for any infectious disease screening, including human immunodeficiency virus (HIV) antibody and p24 antigen, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) IgG antibody, or Treponema pallidum (syphilis) antibody.",true,"MALE","18 Years","55 Years",{"count":21,"type":22},294,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","This is a randomized, double-blind, three-arm, parallel-group study designed to demonstrate the similarity of the pharmacokinetics (PK), safety, and immunogenicity of GS101 injection compared with U.S. commercial Dupixent® and CN commercial Dupixent® in healthy adult participants in China. A total of 294 healthy male adult participants, with 98 participants per treatment group across 3 groups.",[28],"Atopic Dermatitis (AD)","RECRUITING","2026-05-18",{"date":32,"type":33},"2026-05-20","ACTUAL",{"date":35,"type":33},"2026-03-05",{"date":37,"type":22},"2026-09",{"name":39,"class":40},"Jiangsu Genscend Biopharmaceutical Co., Ltd","INDUSTRY",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":49,"minAge":18,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":53,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":41},"100622678","phase-3-a-phase-iii-study-of-gs101-injection-to-dupixent-100622678","NCT07386743","A Phase III Study of GS101 Injection to Dupixent®","A Multicenter, Randomized, Double-blinded, Parallel, Positive-controlled, Phase III Comparative Study to Evaluate GS101 Injection Versus Dupixent® in Participants With Moderate-to-Severe Atopic Dermatitis","Inclusion Criteria:\n\n* Subjects, male or female, between the ages of 18 and 75 years (inclusive)\n* At the time of screening, the diagnosis of atopic dermatitis (AD) meets the Hanifin-Rajka criteria, with a disease history for at least 1 year prior to screening\n* During the screening period and at baseline, patients with moderate-to-severe atopic dermatitis, defined as meeting all of the following 3 criteria concurrently: a. IGA score ≥ 3; b. EASI score ≥ 16; c. BSA ≥ 10%.\n\nExclusion Criteria:\n\n* Hypersensitivity or known allergy to the investigational product(s) or any of their excipients\n* Treatment with any investigational drug, medical device, or other biologic agent within 8 weeks prior to randomization or within 5 half-lives (if the half-life is known), whichever is longer\n* Receipt of any live or live-attenuated vaccine within 3 months prior to randomization, or planned receipt of such vaccines during the study period","ALL","75 Years",{"count":52,"type":22},572,[54],"PHASE3","This is a a multicenter, randomized, double-blinded, parallel, positive-controlled, Phase III comparative study to evaluate GS101 Injection versus Dupixent® in participants with moderate-to-severe atopic dermatitis. A total of 572 subjects are planned to be included and randomized at a ratio of 1:1 to receive GS101 injection or Dupixent®",[28],"NOT_YET_RECRUITING","2026-02-02",{"date":60,"type":33},"2026-02-04",{"date":62,"type":22},"2026-02",{"date":64,"type":22},"2028-01",{"name":39,"class":40},""]