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drugset / Trial / NCT07334496

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

NCT07334496 ↗

Phase 1 Not yet recruiting 198 enrolled Gan & Lee Pharmaceuticals.
RandomizedParallel-groupTriple-blindOther

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.

Timeline

Start
2026-03-09
Primary completion
2026-07-17
Completion
2026-07-17

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dupilumab Monoclonal antibody 300 mg Subcutaneous
Subject GLR1044 Unknown 300 mg Subcutaneous

Indications

No indication recorded.