Clinical Research Directory
Browse clinical research sites, groups, and studies.
A Phase I Study of 9MW4113 Injection Versus Dupixent®
Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.
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
Conditions
Interventions
9MW4113 injection
"9MW4113 injection; 300mg/2.0mL; subcutaneous injection.
Dupilumab
"Dupixent®; 300mg/2.0mL; subcutaneous injection.
Locations (1)
Wuhan Jinyintan Hospital(Wuhan Infectious Disease Hospital)
Wuhan, Hubei, China