Actively Recruiting
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
Led by Shanghai Minwei Biotechnology Co., Ltd · Updated on 2025-11-20
60
Participants Needed
2
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a Phase 1 clinical trial to study MWN109 tablets in healthy adult volunteers. The study aims to evaluate the safety, tolerability, pharmacokinetics (how the drug moves through the body), pharmacodynamics (how the drug affects the body), and immunogenicity (immune response) of MWN109. The trial involves adults aged 18 to 60 years and includes both single and multiple ascending dose phases to understand the drug's effects better. The trial has two parts: a single ascending dose (SAD) phase and a multiple ascending dose (MAD) phase. In the SAD phase, participants receive one oral dose of MWN109 or placebo in four dose levels (7.5mg, 15mg, 30mg, and 45mg). In the MAD phase, participants receive daily doses of MWN109 or placebo for 28 or 30 days, with doses determined based on safety and pharmacokinetic data from the SAD phase. The study uses a randomized, double-blind, placebo-controlled design, meaning neither participants nor researchers know who receives the drug or placebo during the trial. Participants will be closely monitored throughout the study, which lasts up to 8 weeks for the SAD part and 12 weeks for the MAD part. Researchers will assess safety by tracking adverse events, vital signs, ECG changes, physical exams, laboratory tests, and immune responses. Pharmacokinetic measures such as drug concentration over time will also be collected. Participants will follow study requirements including maintaining stable diet and activity levels, and contraception use. The study is led by Shanghai Minwei Biotechnology Co., Ltd and aims to end after the last participant’s final visit in May 2026.
CONDITIONS
Brief Title
A Study to Evaluate MWN109 Tablets in Healthy Adult Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males or females aged 18 to 60 years at informed consent
- For single ascending dose: BMI 19.0 to 40.0 kg/m2 with body weight >65.0 kg and <130.0 kg
- For multiple ascending dose: BMI 27.0 to 45.0 kg/m2 with body weight >65.0 kg and <130.0 kg
- Stable body weight within 3 months before screening with less than 5% change
- Resting heart rate between 45 and 90 bpm confirmed by 12-lead ECG
- Use of contraception for females of childbearing potential and non-sterile males from screening until 4 months after last dose
- Agreement to refrain from sperm or ova donation from screening until 4 months after last dose
- Willing to maintain current diet and physical activity regimen, except no strenuous activity 72 hours before blood sampling
- Able to understand and sign informed consent and follow study requirements
You will not qualify if you...
- Significant history or symptoms of cardiovascular, metabolic, allergic, endocrine, renal, hepatic, gastrointestinal, hematological, pulmonary, respiratory, dermatological, neurological, gynecological, or psychiatric disorders
- Blood pressure outside 90-159 mmHg systolic or 50-95 mmHg diastolic at screening
- History of insulinoma or recent hypoglycemia events
- Recent febrile illness or active infection
- ECG abnormalities including QTcF >450 msec, QRS duration >120 msec, PR interval >220 msec
- History or family history of thyroid tumors or hormone abnormalities
- Diabetes diagnosis or clinical evidence of diabetes
- History of pancreatitis or gallbladder disease
- Abnormal liver, amylase, lipase, triglycerides, or kidney function tests
- Untreated or uncontrolled thyroid disorders
- Significant gastrointestinal diseases or recent gastrointestinal surgery
- Positive tests for hepatitis B, hepatitis C, or HIV
- Severe psychiatric disorders or recent substance abuse
- Excessive alcohol consumption or positive alcohol/drug tests
- Heavy tobacco or nicotine use
- Pregnancy or breastfeeding
- Intolerance to blood draws
- Recent use of medications affecting gastrointestinal motility or other disallowed drugs
- History of severe allergic reactions or drug hypersensitivity
- Recent participation in other clinical trials or blood donation
- Poor venous access
- Related to study personnel or immediate family
- Any other condition deemed unsuitable by investigators or medical monitor
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 8 weeks
Participants receive a single oral dose of MWN109 tablet or placebo in one of four dose cohorts. Safety, tolerability, and pharmacokinetics are monitored following dosing.
Multiple visits over up to 8 weeks post dose
Duration - Up to 12 weeks
Participants receive daily oral doses of MWN109 tablet or placebo once daily for 28 or 30 days depending on cohort. Safety, tolerability, and pharmacokinetics are monitored throughout dosing and after.
Daily dosing with multiple visits during and after treatment for up to 12 weeks
Trial Site Locations
Total: 2 locations
1
CMAX Clinical Research
Adelaide, South Australia, Australia, 5000
Actively Recruiting
2
Veritus Research
Bayswater, Victoria, Australia, 3153
Not Yet Recruiting
Research Team
Y
Yang Fu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here