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ACTIVE NOT RECRUITING
NCT07791342
PHASE1

A Phase I Study of 9MW4113 Injection Versus Dupixent®

Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.

View on ClinicalTrials.gov

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®.

Official title: A Randomized, Double-Blind, Parallel Study to Evaluate the Pharmacokinetic, Safety, and Immunogenicity Similarity Between 9MW4113 and Dupixent® Following a Single Subcutaneous Dose in Healthy Participants

Key Details

Gender

All

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

208

Start Date

2026-04-22

Completion Date

2026-08-17

Last Updated

2026-08-27

Healthy Volunteers

Yes

Interventions

BIOLOGICAL

9MW4113 injection

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

BIOLOGICAL

Dupilumab

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

Locations (1)

Wuhan Jinyintan Hospital(Wuhan Infectious Disease Hospital)

Wuhan, Hubei, China