Phase I Clinical Study of MWN109 Tablets in Healthy Chinese Participants

NCT07787611 | Completed Phase 1

• 1 other identifier: MWN109 Oral-I
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events (AEs)

  The incidence of adverse events (AEs) and serious adverse events (SAEs).

  From Day 1 to Day 42

Secondary Outcomes (12)

• Maximum Concentration (Cmax)

  From Day 1 to Day 15

• Time to Reach Maximum Concentration (Tmax)

  From Day 1 to Day 15

• Area Under the Curve From Time 0 to Last Quantifiable Time Point (AUC0-t)

  From Day 1 to Day 15

• Area Under the Curve From Time 0 to Infinity (AUC0-inf)

  From Day 1 to Day 15

• Elimination Half-Life (t1/2)

  From Day 1 to Day 15

Study Arms (2)

MWN109 Cohort A

EXPERIMENTAL

MWN109 Cohort A consists of 6 dose groups. In all dose groups, healthy participants are randomized to receive oral MWN109 tablets or placebo under fasted or fed conditions.

Drug: MWN109 tablet; Drug: Placebo

MWN109 Cohort B

EXPERIMENTAL

MWN109 Cohort B consists of 4 dose groups. In all dose groups, healthy participants are randomized to receive oral MWN109 tablets or placebo once daily for a total of 4 weeks of treatment.

Drug: MWN109 tablet; Drug: Placebo

Interventions

MWN109 tablet DRUG

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

MWN109 Cohort A

Placebo DRUG

administered orally

MWN109 Cohort A; MWN109 Cohort B

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female participants aged 18 to 50 years (inclusive at the time of signing the informed consent form).
• Body mass index (BMI) = weight (kg) / height squared (m²): SAD part: 19.0 to 29.9 kg/m² (inclusive), with body weight ≥ 55 kg (male) or ≥ 50 kg (female); MAD part: 24.0 to 37.5 kg/m² (inclusive), with body weight ≥ 70 kg (male) or ≥ 60 kg (female).
• Resting heart rate/pulse ≥ 55 beats/min and ≤ 90 beats/min at screening and before randomization.

You may not qualify if:

• History of severe drug allergy (especially known or suspected allergy to the excipients of MWN109 tablets), severe atopic allergic disease/history (e.g., asthma, urticaria, eczematous dermatitis), or a severe allergic constitution.
• History of acute or chronic pancreatitis, symptomatic gallbladder disease, pancreatic injury, or other high-risk factors that may lead to pancreatitis, or amylase or lipase \> 1.5 times the upper limit of normal (ULN) at screening.
• Family history or history of medullary thyroid carcinoma; history of thyroid insufficiency or abnormal thyroid hormone levels.
• Gastrointestinal diseases present at screening that may increase participant risk, such as abnormal gastric emptying (e.g., gastroparesis, pyloric stenosis, pyloric obstruction) or severe chronic gastrointestinal diseases (e.g., history of intestinal obstruction, active ulcer within 6 months).
• History of infectious disease within 4 weeks prior to screening (which, in the investigator's judgment, may significantly affect the safety evaluation of the participant), or severe trauma or major surgery within 3 months.
• History of severe arrhythmia prior to screening judged by the investigator as unsuitable for participation in this study.
• Any of the following abnormal laboratory findings at screening: a) fasting blood glucose ≥ 7.0 mmol/L or \< 3.9 mmol/L, or HbA1c \> 6.5%; b) estimated glomerular filtration rate (eGFR) \< 90 mL/min/1.73 m²; c) triglycerides (TG) ≥ 5.65 mmol/L.
• Blood donation, significant blood loss (\> 400 mL), or receipt of blood transfusion within 3 months prior to screening.

Sponsors & Collaborators

• Shanghai Minwei Biotechnology Co., Ltd: lead

Study Sites (1)

The First Affiliated Hospital of Yunnan University of Chinese Medicine (Yunnan Provincial Hospital of Traditional Chinese Medicine)

Kunming, Yunnan, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: August 26, 2026
• Study Start: June 27, 2025
• Primary Completion: December 20, 2025
• Study Completion: December 20, 2025
• Last Updated: August 26, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)