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RECRUITING
NCT07411755
PHASE1

A Phase 1 Study of GS101 Injection

Sponsor: Jiangsu Genscend Biopharmaceutical Co., Ltd

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.

Official title: 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

Key Details

Gender

MALE

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

294

Start Date

2026-03-05

Completion Date

2026-09

Last Updated

2026-03-11

Healthy Volunteers

Yes

Interventions

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

Locations (1)

The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China