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NOT YET RECRUITING
NCT07779980
PHASE1

Phase 1 Clinical Study of MWN110 Injection in Healthy Participants and Overweight or Obese Participants

Sponsor: Shanghai Minwei Biotechnology Co., Ltd

View on ClinicalTrials.gov

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

Interventions

DRUG

MWN110

S1, S2, S3, S4, S5, S6, S7, S8; administered subcutaneously (SC)

DRUG

MWN110

M1, M2; administered SC

DRUG

MWN110

M3; administered SC

DRUG

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