Recruiting
Phase 1
A Study of MI226 Injection for Abdominal Fat Accumulation
Condition(s) studied
Abdominal Fat
Investigational drug(s) / intervention(s)
MI226 injection(dose 1)MI226 Injection(dose 2)MI226 Injection(dose 3)MI226 injection(dose 4)MI226 injection(dose 5)MI226 Injection(dose 6)MI226 Injection(dose 7)MI226 injection(dose 8)Placebo
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
Inclusion Criteria:
* Aged ≥18 and \<65 years at the time of screening.
* Male body weight ≥50 kg, female body weight ≥45 kg, and body mass index (BMI) between 19.0 kg/m² and 37.0 kg/m² (inclusive).
* Presence of clinically appreciable abdominal fat accumulation, as assessed by the Clinical Photonumeric Rating Scale (CPnS) with a score of ≥2, and judged by the investigator as sufficient to accommodate the planned number of injections per assigned cohort.
* Willingness to use effective contraceptive measures and to refrain from sperm/egg donation from the screening period until 3 months after the last dose of study drug; and no pregnancy plan during this period.
* Ability to understand and voluntarily participate in the study, agree to comply with all study requirements, and provide written informed consent prior to any study-related procedures.
Exclusion Criteria:
* Presence of any medical or physical condition that, in the judgment of the investigator, may interfere with the evaluation of efficacy or safety (e.g., uncontrolled hypertension, and respiratory, cardiovascular, hepatic, neurological, or thyroid diseases).
* Presence of adipose tissue volume deficiency (e.g., post-traumatic) or immune-mediated lipodystrophy syndromes, including: generalized lipodystrophy (e.g., juvenile dermatomyositis-associated), partial lipodystrophy (e.g., Barraquer-Simons syndrome), or HIV-associated lipodystrophy.
* History of or current clinically relevant skin disease that, in the judgment of the investigator, may affect the assessment of the injection site, or presence of keloid tendency (history of predisposition to hypertrophic scarring or keloid formation).
* History of hypersensitivity (allergy to at least 2 substances) or known allergy to any component of the study drug.
* Serious medical or psychiatric illness that, in the judgment of the investigator, may affect the study results or compromise participant compliance.
* Restricted mobility, history of deep vein thrombosis or pulmonary embolism, or major surgery (within the past 3 months), or long-term hospitalization.
* Known bleeding disorders, or use of medications that may increase the risk of post-injection bleeding (e.g., anticoagulant or antiplatelet therapy that cannot be safely discontinued) within 4 weeks prior to screening.
* Females of childbearing potential who are pregnant, lactating, planning to become pregnant, or not using reliable contraceptive measures, and who are unwilling to use reliable contraception during the study (e.g., transdermal patches, intrauterine device/system \[IUD/IUS\], condoms, abstinence, or partner vasectomy).
* Any other condition that, in the investigator's opinion, may significantly increase the participant's risk, confound the study results, or substantially interfere with the participant's participation in the study.
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 |
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