NCT07334496

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

A Randomized, Double-blind, Single-dose, Parallel Comparison Study to Evaluate the Biosimilarity of GLR1044 Injection and Dupilumab Injection (Dupixent®) in Healthy Chinese Adult Male Subjects

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 198 (estimated)
• Sponsor: Gan & Lee Pharmaceuticals. · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Biosimilarity

Interventions

Type	Name	Description
DRUG	GLR1044 injection	GLR1044 injection 300mg/2.0mL; subcutaneous injection; single dose
DRUG	Dupilumab Injection	Dupilumab Injection 300mg/2.0mL; subcutaneous injection; single dose

Timeline

• Start date: 2026-03-09
• Primary completion: 2026-07-17
• Completion: 2026-07-17
• First posted: 2026-01-12
• Last updated: 2026-01-12

Locations

1 site across 1 country: China