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

Sponsor
Gan & Lee Pharmaceuticals.
Study ID
NCT07334496
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Biosimilarity

Eligibility Criteria

Sex
MALE
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • GLR1044 injection — DRUG
    GLR1044 injection 300mg/2.0mL; subcutaneous injection; single dose
  • Dupilumab Injection — DRUG
    Dupilumab Injection 300mg/2.0mL; subcutaneous injection; single dose

Study Details

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.

Key Dates

Start date
Mar 9, 2026
Status verified
Dec 2025
Primary completion
Jul 17, 2026
Completion
Jul 17, 2026

Study Design

Enrollment
198 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: GLR1044 injection
  • Active Comparator: Dupilumab Injection

Primary Outcome Measure

Pharmacokinetic indicators:Cmax [ Time Frame: Day 1-Day 57 ]

Central Contacts