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

StatusCompleted
PhasePhase 1
Started

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Record History

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  1. Trial completed Show 4 more changesShow less
    • Primary completion date changed from estimate of Sep 2026 to Aug 8, 2026
    • Study completion date changed from estimate of Sep 2026 to Aug 24, 2026
    • Eligibility criteria expanded, about 6 words
    • Site details revised
  2. Study title shortened, about 12 wordsv6
  3. Study title expanded, about 17 wordsv5
  4. Primary endpoint(s) modifiedv4
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Mar 2026 to Mar 5, 2026
    • Site details revised
    v3
  6. Study title shortened, about 2 wordsv2
  7. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07411755
Lead Sponsor Jiangsu Genscend Biopharmaceutical Co., Ltd
Conditions
(from sponsor)		 Atopic Dermatitis (AD)
Related terms Dermatitis, Atopic
Enrollment 294 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov