A Study to Evaluate MWN109 Tablets in Healthy Adult Participants

ConditionOverweight or Obesity

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18-60

SponsorShanghai Minwei Biotechnology Co., Ltd

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Males or females aged 18 to 60 years (inclusive) at the time of signing the informed consent (Caucasians should be no less than 80% since the implementation of Protocol Clarification Letter #2, dated 02 Sep 2025).

[Part A: SAD] Body mass index (BMI) of 19.0 to 40.0 kg/m2 (inclusive) with body weight > 65.0 kg and <130.0 kg. [Part B: MAD] BMI of 27.0 to 45.0 kg/m2 (inclusive) with body weight > 65.0 kg and <130.0 kg.

Stable body weight within 3 months before screening (defined as self-reported change < 5%).

Resting heart rate (supine) ≥ 45 bpm and ≤ 90 bpm with a single 12-lead ECG at Screening. If the heart rate is > 90 or < 45 bpm, it is to be repeated 2 more times (separated by at least 2 min) and the average of the 3 heart rate values is to be used to determine the participant's eligibility.

Disqualifiers

Significant history or clinical manifestation of any cardiovascular, metabolic, allergic, endocrine, renal, hepatic, gastrointestinal, hematological, pulmonary, respiratory, dermatological, neurological, gynecological, psychiatric disorders, as determined by the Principal Investigator (or delegate).

Screening blood pressure in supine outside the ranges 90-159 mmHg systolic, 50-95 mmHg diastolic. If abnormal blood pressure is observed, the blood pressure is to be repeated 2 more times, and the average of the 3 blood pressure values is to be used to determine the participant eligibility.

History of insulinoma, or has an event of blood glucose < 2.8 mmol/L within 1 year prior to Screening, or with ≥ 3 times of hypoglycemia symptoms within 3 months prior to Screening.

History of febrile illness within 7 days prior to the first dose of IP or participants with evidence of active infection.

Trial design

Design model

Sequential

Treatments tested in this trial

MWN109 tablet
Drug
Strength: 4mg, 7.5mg, 15mg, 30mg, and 45 mg; Administration: Oral.
Placebo
Drug
Administration: Oral.

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: PlaceboPlacebo comparator 1 intervention

Group B: MWN109 tabletsActive comparator 1 intervention

Trial outcomes

Primary outcomes

Number of participants with Incidence of treatment emergent adverse events (TEAEs) following treatment administration

Time frame