Actively Recruiting
A Study to Evaluate MWN109 Tablets in Healthy Adult Participants
Led by Shanghai Minwei Biotechnology Co., Ltd · Updated on 2025-11-20
60
Participants Needed
2
Research Sites
45 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Evaluate MWN109 Tablets in Healthy Adult Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 60 years at the time of consent
- Caucasians should be no less than 80% of participants
- For the single ascending dose (SAD) part: BMI between 19.0 and 40.0 kg/m2 with body weight between 65.0 and 130.0 kg
- For the multiple ascending dose (MAD) part: BMI between 27.0 and 45.0 kg/m2 with body weight between 65.0 and 130.0 kg
- Stable body weight with less than 5% change in the 3 months before screening
- Resting heart rate between 45 and 90 bpm confirmed by up to three measurements
- Women of childbearing potential and men not surgically sterile must agree to use contraception from screening until 4 months after last dose
- Women of non-reproductive potential defined by menopause or surgical history are eligible
- Men must agree to avoid sperm donation and women to avoid ova donation during the study and 4 months after last dose
- Willing to maintain current diet and physical activity except for avoiding strenuous activity 72 hours before blood sampling
- Able to understand and sign informed consent and follow study requirements
You will not qualify if you...
- History or clinical evidence of significant 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 range at screening
- History of insulinoma or recent hypoglycemia events
- Recent febrile illness or active infection
- Abnormal ECG parameters including QTcF > 450 msec, QRS duration > 120 msec, PR interval > 220 msec
- History or family history of thyroid C-cell tumor, multiple endocrine neoplasia syndrome type 2, or thyroid hormone abnormalities
- History or evidence of diabetes or use of hypoglycemic drugs
- History of pancreatitis or gallbladder disease
- Certain laboratory abnormalities including elevated amylase, lipase, liver enzymes, bilirubin, triglycerides, or low kidney function
- Untreated or uncontrolled thyroid disorders
- Clinically significant gastrointestinal diseases or symptoms
- History or plan of gastrointestinal surgery except appendectomy
- Positive tests for hepatitis B, hepatitis C, or HIV
- Severe psychiatric disorders or history of suicidal behavior
- Alcohol or drug abuse within 1 year
- Excessive alcohol consumption
- Positive alcohol or drug screening during screening
- Heavy tobacco or nicotine use
- Unwillingness to avoid strenuous exercise before blood tests
- Pregnancy or lactation
- Intolerance to blood draws
- Long-term use of drugs affecting gastrointestinal motility or recent gastrointestinal surgery
- History of severe allergic reactions or hypersensitivity
- Allergy to investigational product or components
- Recent use of prescription or nonprescription medications that could interfere with the study
- Recent infectious diseases, severe trauma, or major surgery
- Recent vaccination or planned vaccination during study
- Recent blood donation or massive blood loss
- Recent participation in other clinical trials
- Poor venous access
- Study site personnel or immediate family members
- Clinically significant abnormal findings at screening
- Other reasons deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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