Phase I Clinical Study of MWN109 Tablets in Healthy Chinese Participants

Authors
Category Primary study
Registry of TrialsClinicalTrials.gov
Year 2026
This is a randomized, double‐blind, placebo‐controlled, Phase 1 clinical study conductedin China to evaluate the safety, tolerability, pharmacokinetic (PK), and the effect ofmeal timing following single and multiple oral doses of MWN109 tablets in Chineseparticipants.The study consists of a single ascending dose (SAD) part and a multiple ascending dose(MAD) part. The SAD part includes 6 dose cohorts, with further evaluation of the effectsof different meal‐timing conditions at a selected dose level. The MAD part includes 4dose cohorts administered with once‐daily or every‐other‐day dosing regimens for up to 4weeks.Approximately 108 healthy participants aged 18 to 50 years are planned to be enrolled.The primary endpoint is safety, assessed by adverse events, serious adverse events, vitalsigns, physical examinations, laboratory tests, and 12‐lead electrocardiograms. Thesecondary endpoint is the pharmacokinetic characteristics.
Epistemonikos ID: 1fd8ab090bd2df55e7fbe81c5ac82d6d073f43e6
First added on: Aug 26, 2026