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Phase 1 Clinical Study of MWN110 Injection in Healthy Participants and Overweight or Obese Participants
Sponsor: Shanghai Minwei Biotechnology Co., Ltd
Summary
This study is a multicenter, randomized, double-blind, placebo-controlled, single and multiple ascending-dose phase 1 clinical trial aimed at evaluating the safety, tolerability, PK, PD, and immunogenicity of MWN110 Injection in healthy participants and overweight or obese participants. The study consists of two parts: Part 1, a single ascending dose (SAD) study in healthy participants with 8 dose cohorts; and Part 2, a multiple ascending dose (MAD) study in overweight or obese participants with 3 dose cohorts, with a dosing frequency of once weekly or once every 4 weeks. Approximately 103 participants will be enrolled. The primary endpoint is safety and tolerability, assessed by adverse events, vital signs, physical examination, laboratory tests, 12-lead electrocardiogram, and ophthalmic examination. Secondary endpoints include single-dose and multiple-dose PK parameters, PD parameters (body weight, BMI, waist circumference, muscle mass, body fat percentage, visceral fat, subcutaneous fat, bone mineral density), and immunogenicity (anti-drug antibodies).
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Subcutaneous Administrations of MWN110 Injection in Healthy Participants and Overweight or Obese Participants
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
103
Start Date
2026-08-26
Completion Date
2027-08
Last Updated
2026-08-24
Healthy Volunteers
Yes
Conditions
Interventions
MWN110
S1, S2, S3, S4, S5, S6, S7, S8; administered subcutaneously (SC)
MWN110
M1, M2; administered SC
MWN110
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