Status: Not yet recruiting
A Study to Evaluate the Biosimilarity of GLR1044 Injection and Dupilumab Injection (Dupixent®) in Healthy Adult Male Subjects
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.
Participants needed: 198
Trial details
Phase: Phase 1Age: 18-55Biological sex: MaleType: InterventionalSponsor: Gan & Lee Pharmaceuticals.Updated: Jan 12, 2026Locations: 1
Eligibility criteria
1.Voluntarily sign the informed consent form (ICF) before the study, fully under...
1.History of drug abuse within 1 year prior to screening, or positive predose dr...