NCT07411755

A Phase 1 Study of GS101 Injection

A Randomized, Double-blind, Parallel, Single-dose, Phase 1 Clinical Study to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity of GS101 Versus Dupixent® After Subcutaneous Injection

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 294 (estimated)
• Sponsor: Jiangsu Genscend Biopharmaceutical Co., Ltd · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Atopic Dermatitis (AD)

Interventions

Type	Name	Description
DRUG	GS101 injection	300 mg (2.0 mL)/pre-filled syringe Single subcutaneous injection, 5 cm to the left of the umbilicus, under fasting conditions
DRUG	U.S. commercial Dupixent®	300 mg (2.0 mL)/pre-filled syringe Single subcutaneous injection, 5 cm to the left of the umbilicus, under fasting conditions
DRUG	CN commercial Dupixent®	300 mg (2.0 mL)/pre-filled syringe Single subcutaneous injection, 5 cm to the left of the umbilicus, under fasting conditions

Timeline

• Start date: 2026-03-05
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2026-02-17
• Last updated: 2026-03-11

Locations

1 site across 1 country: China