NCT07411755 A Phase 1 Clinical Study Comparing GS101 and Dupixent® After Subcutaneous Injection
| NCT ID | NCT07411755 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Jiangsu Genscend Biopharmaceutical Co., Ltd |
| Condition | Atopic Dermatitis (AD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 294 participants |
| Start Date | 2026-03-05 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 294 participants in total. It began in 2026-03-05 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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. * Body mass index (BMI) between 19 and 26 kg/m² (inclusive) and body weight between 55 and 85 kg (inclusive). * 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. Exclusion Criteria: * History or presence at screening of neurological/psychiatric, respiratory, cardiovascular, gastrointestinal, hematologic/lymphatic, endocrine, musculoskeletal, or any other disease judged by the investigator to interfere with study assessments. * 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. * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07411755 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 55 Years, studying Atopic Dermatitis (AD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07411755 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07411755 currently recruiting?
Yes, NCT07411755 is actively recruiting participants. Contact the research team at lisinian@jxingbio.com for enrollment information.
Where is the NCT07411755 trial being conducted?
This trial is being conducted at Suzhou, China.
Who is sponsoring the NCT07411755 clinical trial?
NCT07411755 is sponsored by Jiangsu Genscend Biopharmaceutical Co., Ltd. The trial plans to enroll 294 participants.
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