NCT07502534

A Clinical Study Comparing the Bioequivalence of IBI3027 and DUPIXENT®(Dupilumab) in Healthy Chinese Volunteers

A Phase I, Randomized, Double-masked, Parallel-group Clinical Trial Evaluating the Bioequivalence and Safety of a Single Subcutaneous Dose of IBI3027 Monoclonal Antibody Injection Versus DUPIXENT® (Dupilumab) in Healthy Adult Chinese Male Volunteers.

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study is a multicenter, randomized, double-masked, parallel-group, reference-drug-controlled clinical trial of IBI3027 in healthy male volunteers. Healthy volunteers will be randomly assigned in a 1:1 ratio to receive either IBI3027 or DUPIXENT?. The dosage for both groups is 300 mg. The entire study includes a 28-day screening period and a 56-day observation period (including 3 days of hospitalization). Randomization is stratified by body weight at baseline (D1) ≤ 70 kg vs. \> 70 kg.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	IBI3027	The participants in IBI3027 treatment group will receive a 300 mg subcutaneous injection of IBI3027 on the first day.
DRUG	DUPIXENT® (dupilumab)	The participants in DUPIXENT® (dupilumab) treatment group will receive a 300 mg subcutaneous injection of DUPIXENT® (Dupilumab Injection) on the first day.

Timeline

• Start date: 2026-04-20
• Primary completion: 2026-08-04
• Completion: 2026-08-04
• First posted: 2026-03-31
• Last updated: 2026-03-31

Locations

1 site across 1 country: China