Phase 1a Single Ascending Dose Study of MIB-725 in Healthy Adults

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age19-60
SponsorMetro International Biotech, LLC

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

32 Participants
are divided into 1 treatment group

Sponsors and collaborators

Metro International Biotech, LLC

Lead sponsor

Brigham and Women's Hospital

Sponsor institution