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A Phase 1 Study of GS101 Injection
Sponsor: Jiangsu Genscend Biopharmaceutical Co., Ltd
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
Conditions
Interventions
GS101 injection
300 mg (2.0 mL)/pre-filled syringe Single subcutaneous injection, 5 cm to the left of the umbilicus, under fasting conditions
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
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