A Study of MI226 Injection for Abdominal Fat Accumulation
Condition(s) studied
Investigational drug(s) / intervention(s)
MI226 injection(dose 1): Single injection into the subcutaneous adipose tissue.
MI226 Injection(dose 2): Single injection into the subcutaneous adipose tissue.
MI226 Injection(dose 3): Single injection into the subcutaneous adipose tissue.
MI226 injection(dose 4): Single injection into the subcutaneous adipose tissue.
MI226 injection(dose 5): Single injection into the subcutaneous adipose tissue.
MI226 Injection(dose 6): Single injection into the subcutaneous adipose tissue.
MI226 Injection(dose 7): Single injection into the subcutaneous adipose tissue.
MI226 injection(dose 8): Single injection into the subcutaneous adipose tissue.
Placebo: Placebo
Study summary
This is a Phase 1, randomized, double-blind (with open-label sentinel cohorts), placebo-controlled, single-ascending-dose study designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of MI226 Injection in participants with abdominal fat accumulation.
Eligibility
Primary outcome measure(s)
- Incidence and severity of treatment-emergent adverse events (TEAEs) as assessed by NCI CTCAE v6.0 — Up to Day 28
Safety and tolerability will be evaluated by recording adverse events. AEs will be graded according to NCI CTCAE v6.0. - Number of participants with clinically significant abnormal physical examination findings — Up to Day 28
Physical examination includes general appearance, skin, head and neck (eyes, ears, nose, throat), chest and lungs, cardiovascular system, abdomen, extremities, and neurological system. Clinically significant abnormalities will be recorded and summarized by system organ class. - Number of participants with clinically significant changes in vital signs — Up to Day 28
Vital signs include systolic blood pressure (mmHg), diastolic blood pressure (mmHg), pulse rate (bpm), respiratory rate (breaths/min), and body temperature (°C). Clinically significant abnormalities in any of these parameters will be counted as an event. - Number of participants with clinically significant abnormal laboratory test results — Up to Day 7
Laboratory examinations include hematology, serum chemistry, and urinalysis. Abnormalities will be graded according to CTCAE v6.0, and the number of participants with Grade ≥ 1 or clinically significant shifts from baseline will be summarized. - Number of participants with clinically significant abnormal 12-lead electrocardiogram (ECG) findings — Up to Day 7
ECG parameters include heart rate (bpm), PR interval (msec), QRS duration (msec), and QT interval (msec). Clinically significant abnormalities will be recorded.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | Recruiting |
More Nanjing Minova Pharmaceutical Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07749742 on ClinicalTrials.gov ↗ ← All trials in China