A Phase 1 Clinical Study Comparing GS101 and Dupixent® After Subcutaneous Injection

Recruiting now · Phase 1

Conditions studied: Atopic Dermatitis (AD)

In brief

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.

Key facts

Study ID

NCT07411755

Run by

Jiangsu Genscend Biopharmaceutical Co., Ltd

People needed

294

Starts

2026-03-05

Expected to finish

2026-09-01

Last updated by the study team

2026-05-20

Who can join

Age: 18 and older, up to 55. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• The Second Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (enrolling)

Full record on ClinicalTrials.gov

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