drugset / Trial / NCT07411755

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

NCT07411755

Phase 1 Recruiting 294 enrolled Jiangsu Genscend Biopharmaceutical Co., Ltd
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

EvaluationDrugModalityDoseRoute
Comparator Dupilumab Monoclonal antibody 300 mg Subcutaneous
Subject aganirsen Unknown 300 mg Subcutaneous

Indications