About this trial
This is a single center, open label (i.e. participants and study staff will not be masked to the intervention) single ascending dose study to evaluate the safety, tolerability, pharmaokinetics and pharmacodynamics of MIB-725 in community dwelling, healthy adults. Up to 4 successive groups (cohorts) of 8 subjects each will be enrolled in this trial.
This study will determine the safety and tolerability of orally administered single ascending (increasing) doses (100, 200, 400, and 800 mg) of MIB-725 in healthy adults. The safety will be assessed by evaluating physical examination that includes an external eye examination, vital signs, adverse events, and changes in blood counts, EKG, urinalysis, coagulation measures, and blood chemistries, including but not limited to blood glucose, electrolytes, creatinine, liver function tests, uric acid, and creatine kinase.
Eligibility criteria
Qualifiers
Is a non-smoking healthy adult, 19 to 60 years of age, inclusive
Has a body mass index (BMI) between 19 and 37.5 kg/m2, inclusive
Is free from clinically significant medical problems as determined by the Investigator
Is able and willing to provide written informed consent.
Disqualifiers
Is a current cigarette smoker
AST or ALT > 1.5 times the upper limit of normal
Hematocrit < 37% or > 51%
Diagnosis of diabetes mellitus, as indicated by use of diabetes medication, hemoglobin A1C > 6.4% or fasting glucose ≥126 mg/dL
Trial design
Treatments tested in this trial
- MIB-725
Treatment groups
Sponsors and collaborators
Metro International Biotech, LLC
Lead sponsor
Brigham and Women's Hospital
Sponsor institution