๐ฌIn plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
1. 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).
2. \[Part A: SAD\] 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.
3. Stable body weight within 3 months before screening (defined as self-reported change \< 5%).
4. Resting heart rate (supine) โฅ 45 bpm and โค 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.
5. 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
6. 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.
7. 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.
8. Able to comprehend and willing to sign an informed consent form (ICF) and to abide by all study requirements and restrictions.
Exclusion Criteria:
1. 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).
2. 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.
3. History of insulinoma, or has an event of blood glucose \< 2.8 mmol/L within 1 year prior to Screening, or with โฅ 3 times of hypoglycemia symptoms within 3 months prior to Screening.
4. History of febrile illness within 7 days prior to the first dose of IP or participants with evidence of active infection.
5. Any of the following:
1. QTcF \> 450 msec confirmed by repeat measurement;
2. QRS duration \> 120 msec confirmed by repeat measurement;
3. PR interval \> 220 msec confirmed by repeat measurement. Notes: Regarding a), b) and c), ECG is to be repeated 2 more times when out-of-range and the average of the values is to be used to determine the participant eligibility;
4. Findings which would make QTc measurements difficult or QTc data uninterpretable;
5. History of additional risk factors for torsades de pointes (e.g., heart failure, hypokalemia, family history of long QT syndrome).
6. Known history or family history of thyroid C-cell tumor/carcinoma, multiple endocrine neoplasia syndrome type 2 (MEN2), thyroid dysfunction or thyroid hormone abnormality.
7. History of diabetes mellitus or clinical evidence of diabetes (e.g., hemoglobin A1c โฅ 6.5%, fasting plasma glucose โฅ 126 mg/dL \[7.0 mmol/L\]) at Screening, non-fasting plasma glucose โฅ 200 mg/dL (11.1 mmol/L) at Screening, or use of any hypoglycemic drugs during Screening or within 3 months prior to Screening.
8. History of acute or chronic pancreatitis, symptomatic gallbladder disease, pancreatic injury and other high-risk factors that may lead to pancreatitis.
9. With any of following laboratory abnormality at screening and confirmed by a single repeat at the discretion of the Principal Investigator (or delegate):
a) Elevation in serum amylase or lipase (\> 1.5 ร upper limit of normal \[ULN\]). b) Have serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 1.5 ร ULN or total bilirubin \>1.5 ร ULN.
c) Have serum triglycerides (TG) โฅ 5.65 mmol/L (500 mg/dL) at Screening. d) Estimated glomerular filtration rate (eGFR) \< 80 mL/min/1.73m2 by Cockcroft-Gault equation as below: (140 - age) ร mass (kg)/72 ร creatinine (mg/dL); multiply by 0.85 if female.
10. Untreated or uncontrolled hypothyroidism/hyperthyroidism defined as thyroid-stimulating hormone \> 6 mIU/L or \< 0.4 mIU/L.
11. History of clinically significant (in the opinion of the Principal Investigator or delegate) abnormal gastric emptying (e.g., gastric outlet obstruction, gastroparesis), chronic gastrointestinal diseases (e.g., having active ulcer within 6 months prior to Screening, active gastritis or esophagitis, or gastroesophageal reflux disease, irritable bowel disease or severe inflammatory bowel disease).
12. Presence of clinically significant acute gastrointestinal symptoms (e.g., nausea, vomiting, heartburn or diarrhoea) or malabsorptive states (celiac disease, lactose intolerance or chronic pancreatitis), as judged by the Principal Investigator (or delegate).
13. Any history or plan of gastrointestinal surgery excluding appendectomy.
14. Positive hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), or human immunodeficiency virus (HIV-1 and HIV-2) antibodies.
15. Any history of severe psychiatric disorder such as major depressive disorder, bipolar disorder, and s