Clinical Trial

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

Recruiting Phase 1
View on ClinicalTrials.gov →
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.
Protocol Amendment History 1 change
critical Primary endpoint(s) modified 2026-04-25
Trial Details
NCT Number NCT07411755
Lead Sponsor Jiangsu Genscend Biopharmaceutical Co., Ltd
Conditions Atopic Dermatitis (AD)
Enrollment 294 participants
Start Date 2026-03-05
Primary Completion 2026-09 (estimated)
Study Completion 2026-09 (estimated)
Updated on ClinicalTrials.gov 2026-05-20