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NOT YET RECRUITING
NCT07334496
PHASE1

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

Sponsor: Gan & Lee Pharmaceuticals.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

MALE

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

198

Start Date

2026-03-09

Completion Date

2026-07-17

Last Updated

2026-01-12

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

GLR1044 injection

GLR1044 injection 300mg/2.0mL; subcutaneous injection; single dose

DRUG

Dupilumab Injection

Dupilumab Injection 300mg/2.0mL; subcutaneous injection; single dose

Locations (1)

Beijing Gobroad Hospital

Beijing, Beijing Municipality, China