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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Metro International Biotech, LLC
Study ID
NCT06815991
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Healthy Adults

Eligibility Criteria

Sex
ALL
Age
19 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • MIB-725 — DRUG
    MIB-725 is a modified precursor of the NAD+ biosynthetic pathway.

Study Details

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.

Key Dates

Start date
Feb 11, 2025
Status verified
Feb 2026
Primary completion
Dec 31, 2026
Completion
Mar 31, 2027

Study Design

Enrollment
32 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Safety and pharmacokinetic single dose ascending dose study
    This is a single dose ascending study in which 100, 200, 400, or 800 mg of MIB-725 will be administered as a single oral dose in ascending order starting with the lowest (100 mg) dose

Primary Outcome Measure

Treatment-emergent adverse events [ Time Frame: Baseline to 28 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115
Nancy K Latham, PhD
[email protected]
1-617-525-9150
Shalender Bhasin, MB, BS (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By research site
Brigham and Women's Hospital· Boston, MA

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