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Phase 1 Clinical Study of MWN109 Injection in Healthy Chinese Volunteers
Sponsor: Shanghai Minwei Biotechnology Co., Ltd
Summary
This is a randomized, double-blind, placebo-controlled, single- and multiple- dose-escalating Phase 1a study. The objective is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of MWN109 Injection in healthy Chinese volunteers and to provide data for subsequent clinical trials. The study includes a single ascending dose (SAD) part with 4 dose cohorts and a multiple ascending dose (MAD) part with 3 dose cohorts, using a 3-week dose titration regimen. Approximately 58 volunteers will be enrolled. The primary endpoint is safety, assessed by adverse events, serious adverse events, vital signs, physical examinations, laboratory tests, and 12-lead electrocardiograms. The secondary endpoint is the pharmacokinetic characteristics.
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase 1a Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Subcutaneous Dose Escalation of MWN109 Injection in Healthy Chinese Volunteers
Key Details
Gender
All
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
48
Start Date
2024-12-18
Completion Date
2025-07-20
Last Updated
2026-08-26
Healthy Volunteers
Yes
Conditions
Interventions
MWN109
S1, S2 S3, S4; administered subcutaneously (SC)
MWN109
M1, M2, M3; administered SC
Placebo
administered SC
Locations (1)
The First Affiliated Hospital of Yunnan University of Chinese Medicine (Yunnan Provincial Hospital of Traditional Chinese Medicine)
Kunming, Yunnan, China