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NOT YET RECRUITING
NCT07502534
PHASE1

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

Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

View on ClinicalTrials.gov

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.

Official title: 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.

Key Details

Gender

MALE

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

180

Start Date

2026-04-20

Completion Date

2026-08-04

Last Updated

2026-03-31

Healthy Volunteers

Yes

Interventions

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.

Locations (1)

Qingdao University Affiliated Hospital

Qingdao, Shandong, China