drugset / Trial / NCT07411755
A Phase 1 Clinical Study Comparing GS101 and Dupixent® After Subcutaneous Injection
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2026-03-05
- Primary completion
- 2026-09
- Completion
- 2026-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Dupilumab | Monoclonal antibody | 300 mg | Subcutaneous |
| Subject | aganirsen | Unknown | 300 mg | Subcutaneous |