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

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.

NCT Number	NCT06815991
Lead Sponsor	Metro International Biotech, LLC
Conditions	Healthy Adults
Enrollment	32 participants
Start Date	2025-02-11
Primary Completion	2026-12 (estimated)
Study Completion	2027-03 (estimated)
Updated on ClinicalTrials.gov	2026-02-19