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Phase 1 Clinical Study of MWN105 Injection in Healthy Chinese Volunteers

StatusCompleted
PhasePhase 1
Started2024-12-19
View on ClinicalTrials.gov ↗
This study is a randomized, double-blind, placebo-controlled, single-dose and multiple-dose, dose-escalation phase I clinical trial, aiming to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic characteristics, and immunogenicity of MWN105 injection in healthy Chinese volunteers, and to provide a reference for the next clinical trial. This study includes a single ascending dose (SAD) study and a multiple ascending dose (MAD) study. The SAD study consists of 4 dose groups; the MAD study consists of 2 dose groups and adopts a 4-week dose titration scheme. The study plans to enroll 55 volunteers. The primary endpoint is the incidence of adverse events. The secondary endpoints are the pharmacokinetic and pharmacodynamic characteristics and immunogenicity endpoints.
Trial Details
NCT Number NCT07801313
Lead Sponsor Shanghai Minwei Biotechnology Co., Ltd
Conditions Overweight , Obesity, Type 2 Diabetes Mellitus (T2DM), MASH - Metabolic Dysfunction-Associated Steatohepatitis
Enrollment 55 participants
Start Date 2024-12-19
Primary Completion 2025-07-20 (estimated)
Study Completion 2025-07-20 (estimated)
Updated on ClinicalTrials.gov 2026-09-03