Overview

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

Status:
NOT_YET_RECRUITING

Trial end date:
2026-07-17

Target enrollment:

Participant gender:

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.

Phase:

PHASE1

Details

Lead Sponsor:

Gan & Lee Pharmaceuticals.

Treatments:

dupilumab