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Phase 1 Clinical Study of MWN105 Injection in Healthy Chinese Volunteers
Sponsor: Shanghai Minwei Biotechnology Co., Ltd
Summary
This study is a randomized, double-blind, placebo-controlled, single-dose and multiple-dose, dose-escalation phase I clinical trial, aiming to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic characteristics, and immunogenicity of MWN105 injection in healthy Chinese volunteers, and to provide a reference for the next clinical trial. This study includes a single ascending dose (SAD) study and a multiple ascending dose (MAD) study. The SAD study consists of 4 dose groups; the MAD study consists of 2 dose groups and adopts a 4-week dose titration scheme. The study plans to enroll 55 volunteers. The primary endpoint is the incidence of adverse events. The secondary endpoints are the pharmacokinetic and pharmacodynamic characteristics and immunogenicity endpoints.
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Subcutaneous Ascending Doses of MWN105 Injection in Healthy Chinese Volunteers
Key Details
Gender
All
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
55
Start Date
2024-12-19
Completion Date
2025-07-20
Last Updated
2026-09-03
Healthy Volunteers
Yes
Conditions
Interventions
MWN105
S1, S2 S3, S4; administered subcutaneously (SC)
MWN105
M1, M2; administered SC
Placebo
administered SC
Locations (1)
Hangzhou First People's Hospital
Hangzhou, Zhejiang, China