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
Qualifiers
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
Treatments tested in this trial
- 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
Treatment groups
52 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov