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NOT YET RECRUITING
NCT07824804
PHASE1

Phase 1 Clinical Study of MWN117 Injection in Healthy Participants and Participants With Obesity

Sponsor: Shanghai Minwei Biotechnology Co., Ltd

View on ClinicalTrials.gov

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

Interventions

DRUG

MWN117

A1, A2; administered subcutaneously (SC)

DRUG

MWN117

B1, B2, B3, B4; 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