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Phase 1 Clinical Study of MWN117 Injection in Healthy Participants and Participants With Obesity
Sponsor: Shanghai Minwei Biotechnology Co., Ltd
Summary
This study is a randomized, double-blind, placebo-controlled, single-dose, dose-escalation Phase 1 clinical trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of MWN117 injection in healthy and obese Chinese participants. The study consists of two parts. Part A includes two dose cohorts enrolling healthy participants, and Part B includes four dose cohorts enrolling obese participants. A total of 48 participants will be enrolled. Within each dose cohort, participants will be randomly assigned to receive a single subcutaneous injection of MWN117 or matching placebo. The primary endpoint is safety, assessed by adverse events and related examinations. Secondary endpoints include plasma pharmacokinetic (PK) parameters and urine PK parameters.
Official title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Subcutaneous Administration of MWN117 Injection in Healthy and Obese Participants
Key Details
Gender
All
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
48
Start Date
2026-09-18
Completion Date
2028-03
Last Updated
2026-09-17
Healthy Volunteers
Yes
Conditions
Interventions
MWN117
A1, A2; administered subcutaneously (SC)
MWN117
B1, B2, B3, B4; 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