Phase 1 Study Comparing GS101 and Dupixent After a Single Subcutaneous Injection in Healthy Adult Males

What this Trial Is About

Researchers are conducting a randomized, double-blind, three-arm, parallel-group Phase 1 study to compare the pharmacokinetics, safety, and immune response of GS101 injection with two versions of Dupixent4 U.S. commercial and China commercial in healthy adult male participants in China. The study involves 294 healthy men aged 18 to 55 years, divided equally among the three treatment groups. This trial aims to demonstrate the similarity between GS101 and the established Dupixent4 treatments. Participants receive a single subcutaneous injection of 300 mg 2.0 mL of either GS101, U.S. commercial Dupixent4, or China commercial Dupixent4. The injection is administered 5 cm to the left of the umbilicus under fasting conditions. The study is designed to maintain blinding and randomization with three parallel treatment arms. During the 10-week study period, researchers will monitor pharmacokinetics as the primary outcome to assess how the drugs behave in the body. Safety, tolerability, and immune responses will also be evaluated through clinical exams, vital signs, lab tests, ECGs, and chest X-rays. Participants and their partners will use contraceptive methods throughout the study and for three months afterward. The study duration and procedures aim to thoroughly assess the comparability of GS101 to Dupixent4 in healthy male adults.

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