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

Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Study ID
NCT07502534
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
MALE
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Apr 24, 2026
Status verified
May 2026
Primary completion
Jul 7, 2026
Completion
Jul 7, 2026

Study Design

Enrollment
180 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: IBI3027 treatment group
    The participants in this group will receive a 300 mg subcutaneous injection of IBI3027 on the first day.
  • Active Comparator: DUPIXENT® (dupilumab) treatment group
    The participants in this group will receive a 300 mg subcutaneous injection of DUPIXENT® (Dupilumab Injection) on the first day.

Primary Outcome Measure

Peak drug concentration (Cmax) [ Time Frame: Days 1-57 ]

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