Phase 1 Study of MWN109 Tablets to Evaluate Safety and Effects in Healthy Adults with Overweight or Obesity

What this Trial Is About

Researchers are conducting a Phase 1 clinical trial to study MWN109 tablets in healthy adult volunteers. The study aims to evaluate the safety, tolerability, pharmacokinetics how the drug moves through the body, pharmacodynamics how the drug affects the body, and immunogenicity immune response of MWN109. The trial involves adults aged 18 to 60 years and includes both single and multiple ascending dose phases to understand the drugs effects better. The trial has two parts a single ascending dose SAD phase and a multiple ascending dose MAD phase. In the SAD phase, participants receive one oral dose of MWN109 or placebo in four dose levels 7.5mg, 15mg, 30mg, and 45mg. In the MAD phase, participants receive daily doses of MWN109 or placebo for 28 or 30 days, with doses determined based on safety and pharmacokinetic data from the SAD phase. The study uses a randomized, double-blind, placebo-controlled design, meaning neither participants nor researchers know who receives the drug or placebo during the trial. Participants will be closely monitored throughout the study, which lasts up to 8 weeks for the SAD part and 12 weeks for the MAD part. Researchers will assess safety by tracking adverse events, vital signs, ECG changes, physical exams, laboratory tests, and immune responses. Pharmacokinetic measures such as drug concentration over time will also be collected. Participants will follow study requirements including maintaining stable diet and activity levels, and contraception use. The study is led by Shanghai Minwei Biotechnology Co., Ltd and aims to end after the last participants final visit in May 2026.

A Study to Evaluate MWN109 Tablets in Healthy Adult Participants