Healthy Volunteers
Conditions
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.
Interventions
DRUGMWN109 tablet
A1, A2, A3a, A3b, A3c, A4; administered orally
DRUGPlacebo
administered orally
Sponsors
Shanghai Minwei Biotechnology Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male or female participants aged 18 to 50 years (inclusive at the time of signing the informed consent form). 2. 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). 3. Resting heart rate/pulse ≥ 55 beats/min and ≤ 90 beats/min at screening and before randomization.
Exclusion criteria
1. 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. 2. 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. 3. Family history or history of medullary thyroid carcinoma; history of thyroid insufficiency or abnormal thyroid hormone levels. 4. 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). 5. 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. 6. History of severe arrhythmia prior to screening judged by the investigator as unsuitable for participation in this study. 7. 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. 8. Blood donation, significant blood loss (\> 400 mL), or receipt of blood transfusion within 3 months prior to screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events (AEs) | From Day 1 to Day 42 | The incidence of adverse events (AEs) and serious adverse events (SAEs). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Concentration (Cmax) | From Day 1 to Day 15 | Cmax of MWN109 and its excipient, salcaprozate sodium (SNAC). |
| Time to Reach Maximum Concentration (Tmax) | From Day 1 to Day 15 | Tmax of MWN109 and its excipient, SNAC. |
| Area Under the Curve From Time 0 to Last Quantifiable Time Point (AUC0-t) | From Day 1 to Day 15 | AUC0-t of MWN109 and its excipient, SNAC. |
| Area Under the Curve From Time 0 to Infinity (AUC0-inf) | From Day 1 to Day 15 | AUC0-inf of MWN109 and its excipient, SNAC. |
| Elimination Half-Life (t1/2) | From Day 1 to Day 15 | t1/2 of MWN109 and its excipient, SNAC. |
| Steady State Maximum Concentration (Cmax,ss) | From Day 1 to Day 42 | Cmax,ss of MWN109 and its excipient, SNAC. |
| Steady State Minimum Concentration (Cmin,ss) | From Day 1 to Day 42 | Cmin,ss of MWN109 and its excipient, SNAC. |
| Steady State Concentration (Cav,ss) | From Day 1 to Day 42 | Cav,ss of MWN109 and its excipient, SNAC. |
| Time to Reach Maximum Concentration at Steady State (Tmax,ss) | From Day 1 to Day 42 | Tmax,ss of MWN109 and its excipient, SNAC. |
| Steady State Apparent Terminal Elimination Half-life (t1/2,ss) | From Day 1 to Day 42 | t1/2,ss of MWN109 and its excipient, SNAC. |
| Area Under Concentration-time Profiles during a Dose Interval (AUC0-τ,ss) | From Day 1 to Day 42 | AUC0-τ,ss of MWN109 and its excipient, SNAC. |
| Steady State Area Under the Curve From Time 0 to Last Quantifiable Time Point (AUC0-t,ss) | From Day 1 to Day 42 | AUC0-t,ss of MWN109 and its excipient, SNAC. |
Countries
China
Outcome results
None listed