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A Phase I Study of 9MW4113 Injection Versus Dupixent®

NCT07791342 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 208

Last updated 2026-08-27

No results posted yet for this study

Summary

It is a randomized, double-blinded, parallel, single-dose, Phase I comparative study to evaluate the pharmacokinetic, safety, and immunogenicity similarity between 9MW4113 and Dupixent® in healthy Chinese adult participants. A total of 208 healthy participants are planned to be included and randomized at a ratio of 1:1 to receive single 300mg/2.0ml 9MW4113 injection or Dupixent®.

Conditions

  • Healthy Participants

Interventions

BIOLOGICAL

9MW4113 injection

"9MW4113 injection; 300mg/2.0mL; subcutaneous injection.

BIOLOGICAL

Dupilumab

"Dupixent®; 300mg/2.0mL; subcutaneous injection.

Sponsors & Collaborators

  • Mabwell (Shanghai) Bioscience Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-04-22
Primary Completion
2026-07-27
Completion
2026-08-17

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT07791342 on ClinicalTrials.gov