Actively Recruiting
A Study to Evaluate MWN109 Injection in Healthy Subjects
Led by Shanghai Minwei Biotechnology Co., Ltd · Updated on 2025-04-15
72
Participants Needed
1
Research Sites
36 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a Phase1, randomized, double-blinded, and placebo-controlled study. In each cohort, enrolled participants will be randomized to receive either placebo or MWN109.
CONDITIONS
Official Title
A Study to Evaluate MWN109 Injection in Healthy Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males or females aged 18 to 50 years at screening
- For Part A (single ascending dose): BMI between 19.0 and 40.0 kg/m2
- For Part B (multiple ascending dose): BMI between 27.0 and 45.0 kg/m2 with minimum body weight of 50.0 kg for females and 55.0 kg for males
- Stable body weight for at least 3 months with less than 5% change
- Resting heart rate (supine) between 45 and 90 bpm with a single 12-lead ECG at screening
- Females of childbearing potential and males agree to use contraception as detailed in the protocol
- Male participants agree to refrain from sperm donation and females from ova donation from one day before dosing until 4 months after last administration
- Able to understand and willing to sign informed consent and comply with study requirements
You will not qualify if you...
- Any significant cardiovascular, metabolic, allergic, endocrine, renal, hepatic, gastrointestinal, hematological, pulmonary, respiratory, dermatological, neurological, gynecological, or psychiatric disorder
- History of pheochromocytoma or uncontrolled blood pressure (systolic 63 160 mmHg or diastolic 63 100 mmHg)
- History of insulinoma or recent significant hypoglycemia
- Recent febrile illness or active infection
- Certain abnormal ECG findings including QTcF > 450 msec, QRS duration > 110 msec, PR interval > 220 msec, or risk factors for torsades de pointes
- Known or family history of thyroid C-cell tumors or related endocrine disorders
- History or evidence of diabetes mellitus
- History of pancreatitis or gallbladder disease
- Significant laboratory abnormalities including elevated amylase, lipase, liver enzymes, triglycerides, or reduced kidney function
- Severe gastrointestinal diseases or recent gastrointestinal surgery
- Long-term use of drugs affecting gastrointestinal motility
- Positive tests for hepatitis B, hepatitis C, or HIV
- Severe psychiatric disorders or recent suicidal ideation or behavior
- History of substance abuse or excessive alcohol use
- Positive alcohol or drug screening tests
- Heavy tobacco use
- Pregnant or lactating females or positive pregnancy test
- Intolerance or adverse reactions to blood draws
- History of severe allergic or hypersensitivity reactions
- Allergy or hypersensitivity to the investigational product
- Use of prohibited medications or supplements prior to dosing
- Recent infectious diseases, severe trauma, surgery, vaccination, or blood donation
- Participation in other clinical studies recently
- Poor venous access
- Study site personnel or immediate family members
- Clinically significant abnormal physical exams, vital signs, ECG, or labs at screening
- Skin conditions or tattoos interfering with injection site evaluation
- Any other reason deemed unsuitable by investigator or medical monitor
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Veritus Research
Melbourne, Victoria, Australia, 3153
Actively Recruiting
Research Team
G
Guitao Zhang
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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