NCT06938269

A Study to Evaluate MWN109 Tablets in Healthy Adult Participants

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MWN109 Tablets in Healthy Adult Participants

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Shanghai Minwei Biotechnology Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 1, randomized, double-blind, placebo-controlled, single-and-multiple ascending dose study in which the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of orally administered MWN109 tablets will be assessed in healthy adult participants.

Detailed description

Approximately 60 healthy volunteers are expected to be enrolled into this study. The study will consist of 2 parts: a single ascending dose (SAD) part and a multiple ascending dose (MAD) part.The SAD part will be a single-dose, sequential-cohort study. The MAD Part will be a multiple-dose, sequential-cohort study. Initiation and dose levels of MAD Part will be determined in the safety review and dose escalation meeting by the Safety Review Committee based on the review of safety, tolerability, and PK data from SAD Part. The entire study duration per participant is estimated to be a maximum of 8 weeks for the single ascending dose (SAD) part and 12 weeks for the multiple ascending dose (MAD) part. The end of study is defined as the date of the last visit of the last participant in the study.

Conditions

• Overweight or Obesity

Interventions

Type	Name	Description
DRUG	MWN109 tablet	Strength: 4mg, 7.5mg, 15mg, 30mg, and 45 mg; Administration: Oral.
DRUG	Placebo	Administration: Oral.

Timeline

• Start date: 2025-06-18
• Primary completion: 2026-03-01
• Completion: 2026-05-01
• First posted: 2025-04-22
• Last updated: 2025-11-20

Locations

2 sites across 1 country: Australia