A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MWN109 Tablets in Healthy Adult Participants
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.
• 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.
• Females of childbearing potential and males who are not surgically sterile (\>180 days since vasectomy with no viable sperm) will agree to use contraception from Screening until 4 months after the last administration, OR females of non-reproductive potential as defined below:
‣ Postmenopausal as defined as:
• No menses for at least 12 months; OR
∙ No menses for at least 12 months AND with a follicle-stimulating hormone level \> 40 IU/L or according to the definition of postmenopausal range for the laboratory involved; OR
⁃ History of hysterectomy; OR
⁃ History of bilateral oophorectomy
• Male participants must agree to refrain from sperm donation and females should refrain from ova donation from Screening until 4 months after the last administration.
• Willing to maintain current general diet and physical activity regimen, except for the physical activity in the 72 h before each blood sample collection for the clinical laboratory analysis, which should not be strenuous, and willing to be restrained from alcohol and smoking during the study period.
• Able to comprehend and willing to sign an informed consent form (ICF) and to abide by all study requirements and restrictions.