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Phase I Clinical Study of MWN109 Tablets in Healthy Chinese Participants

NCT07787611 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2026-08-26

No results posted yet for this study

Summary

This is a randomized, double-blind, placebo-controlled, Phase 1 clinical study conducted in China to evaluate the safety, tolerability, pharmacokinetic (PK), and the effect of meal timing following single and multiple oral doses of MWN109 tablets in Chinese participants.

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 effects of different meal-timing conditions at a selected dose level. The MAD part includes 4 dose cohorts administered with once-daily or every-other-day dosing regimens for up to 4 weeks.

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, vital signs, physical examinations, laboratory tests, and 12-lead electrocardiograms. The secondary endpoint is the pharmacokinetic characteristics.

Conditions

  • Healthy Volunteers

Interventions

DRUG

MWN109 tablet

A1, A2, A3a, A3b, A3c, A4; administered orally

DRUG

MWN109 tablet

B1, B2, B3, B4; administered orally

DRUG

Placebo

administered orally

Sponsors & Collaborators

  • Shanghai Minwei Biotechnology Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-06-27
Primary Completion
2025-12-20
Completion
2025-12-20

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07787611 on ClinicalTrials.gov