A Study of MI226 Injection for Abdominal Fat Accumulation
ConditionAbdominal Fat
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNanjing Minova Pharmaceutical Co., Ltd.
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
MI226 injection（dose 1）
DrugSingle injection into the subcutaneous adipose tissue.
MI226 Injection（dose 2）
DrugSingle injection into the subcutaneous adipose tissue.
MI226 Injection（dose 3）
DrugSingle injection into the subcutaneous adipose tissue.
MI226 injection（dose 4）
DrugSingle injection into the subcutaneous adipose tissue.
MI226 injection（dose 5）
DrugSingle injection into the subcutaneous adipose tissue.
MI226 Injection（dose 6）
DrugSingle injection into the subcutaneous adipose tissue.
MI226 Injection（dose 7）
DrugSingle injection into the subcutaneous adipose tissue.
MI226 injection（dose 8）
DrugSingle injection into the subcutaneous adipose tissue.
Placebo
DrugPlacebo
Treatment groups
52 Participants
are divided into 2 treatment groupsGroup A: MI226 InjectionExperimental treatment 8 interventions
Group B: placeboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Incidence and severity of treatment-emergent adverse events (TEAEs) as assessed by NCI CTCAE v6.0
Safety and tolerability will be evaluated by recording adverse events. AEs will be graded according to NCI CTCAE v6.0.
Time frame
Up to Day 282
Number of participants with clinically significant abnormal physical examination findings
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.
Time frame
Up to Day 283
Number of participants with clinically significant changes in vital signs
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.
Time frame
Up to Day 284
Number of participants with clinically significant abnormal laboratory test results
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.
Time frame
Up to Day 7Secondary outcomes
1
Maximum observed plasma concentration (Cmax) of MI226
Plasma concentrations of MI226 will be measured using a validated LC-MS/MS method. Cmax will be derived using non-compartmental analysis.
Time frame
From pre-dose to 24 hours post-dose2
Time to reach maximum observed plasma concentration (Tmax) of MI226
Plasma concentrations of MI226 will be measured using a validated LC-MS/MS method.
Time frame
From pre-dose to 24 hours post-dose3
Terminal elimination half-life (t1/2) of MI226
Plasma concentrations of MI226 will be measured using a validated LC-MS/MS method.
Time frame
From pre-dose to 24 hours post-dose4
Area under the plasma concentration-time curve from time 0 to infinity (AUC0-inf) of MI226
Plasma concentrations of MI226 will be measured using a validated LC-MS/MS method. AUC0-inf will be derived using non-compartmental analysis.
Time frame
From pre-dose to 24 hours post-doseSponsors and contacts
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Source ClinicalTrials.gov