Phase 1a Single Ascending Dose Study of MIB-725 in Healthy Adults
Summary
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.
Timeline
- Start
- 2025-02-11
- Primary completion
- 2026-12
- Completion
- 2027-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MIB-725 | Unknown | 100 mg | Oral |
| Subject | MIB-725 | Unknown | 200 mg | Oral |
| Subject | MIB-725 | Unknown | 400 mg | Oral |
| Subject | MIB-725 | Unknown | 800 mg | Oral |
Indications
No indication recorded.