Phase 1 Clinical Study of MWN105 Injection in Healthy Chinese Volunteers

StatusCompleted
PhasePhase 1
Started

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
5,101 trials monitored
See 233 trials at risk
3,888 trials monitored
See 157 trials at risk
2,236 trials monitored
See 113 trials at risk
and 1 more disease
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
(from sponsor)
Overweight , Obesity, Type 2 Diabetes Mellitus (T2DM), MASH - Metabolic Dysfunction-Associated Steatohepatitis
Related terms Diabetes Mellitus, Type 2, Obesity, Overweight
Enrollment 55 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov