Clinical Trial

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

Active, Not Recruiting Phase 1
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Record status
This record was last updated May 15, 2026 (before its estimated July 7, 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 change
critical Trial status changed: Not Yet Recruiting → Active, Not Recruiting 2026-05-16
Trial Details
NCT Number NCT07502534
Lead Sponsor Innovent Biologics (Suzhou) Co. Ltd.
Conditions Healthy Volunteers
Enrollment 180 participants
Start Date 2026-04-24
Primary Completion 2026-07-07 (estimated)
Study Completion 2026-07-07 (estimated)
Updated on ClinicalTrials.gov 2026-05-15