Clinical Trial

A Study to Evaluate the Biosimilarity of GLR1044 Injection and Dupilumab Injection (Dupixent®) in Healthy Adult Male Subjects

Not Yet Recruiting Phase 1
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Record status
This record was last updated January 12, 2026 (before its estimated July 17, 2026 completion). Its status may not reflect the trial's current state.
Summary
This is a randomized, double-blind, single-dose, parallel comparison biosimilarity study conducted in healthy Chinese adult male subjects. It is planned to enroll 198 male subjects in this study. Eligible subjects will be randomized into 2 dosing groups at 1:1 (GLR1044 group or Dupilumab group), i.e., 99 subjects in each group. Each subject is administered once by subcutaneous injection in the abdomen, during which the subject is required to be hospitalized for 4 days. The safety follow-up will last until D57.
Trial Details
NCT Number NCT07334496
Lead Sponsor Gan & Lee Pharmaceuticals.
Conditions Biosimilarity
Enrollment 198 participants
Start Date 2026-03-09
Primary Completion 2026-07-17 (estimated)
Study Completion 2026-07-17 (estimated)
Updated on ClinicalTrials.gov 2026-01-12