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

NCT07411755 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 294

Last updated 2026-05-20

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Jiangsu Genscend Biopharmaceutical Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-03-05
Primary Completion
2026-09-30
Completion
2026-09-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07411755 on ClinicalTrials.gov