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Phase 1 Clinical Study of MWX203 Injection in Healthy Subjects
Sponsor: Shanghai Minwei Biotechnology Co., Ltd
Summary
This is a randomized, double-blind, placebo-controlled, single ascending dose Phase 1 study designed to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) profiles of MWX203 Injection in healthy Chinese subjects. The study comprises six dose cohorts with a planned enrollment of 54 subjects. The primary endpoint is safety, assessed by adverse events (AEs), serious adverse events (SAEs), vital signs, physical examinations, laboratory tests, and 12-lead electrocardiograms. Secondary endpoints include plasma PK parameters, urinary PK parameters, and immunogenicity (anti-drug antibodies).
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Single Subcutaneous Administration of MWX203 Injection in Healthy Chinese Subjects
Key Details
Gender
All
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
54
Start Date
2025-07-07
Completion Date
2027-01
Last Updated
2026-09-02
Healthy Volunteers
Yes
Conditions
Interventions
MWX203 S1
administered subcutaneously (SC)
Placebo
administered SC
MWX203 S2
administered SC.
MWX203 S3
administered SC.
MWX203 S4
administered SC.
MWX203 S5
administered SC.
MWX203 S6
administered SC.
Locations (1)
Hangzhou First People's Hospital
Hangzhou, Zhejiang, China