MedTrace Logo

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

NCT07502534 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2026-05-15

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Innovent Biologics (Suzhou) Co. Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-04-24
Primary Completion
2026-07-07
Completion
2026-07-07

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07502534 on ClinicalTrials.gov