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
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
Treatments tested in this trial
- MWN109 tablet
- Placebo
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov