A Phase 1, Single Ascending Dose Administration of MIB-725 to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Community Dwelling Healthy Adults
Metro International Biotech, LLC
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.
Description
Nicotinamide adenine dinucleotide (NAD), a critically important cofactor for the functioning of all living cells, is required for the enzymatic processes that generate energy within the cell, through ATP production during glycolysis, the Krebs cycle, and oxidative phosphorylation (1-3). NAD+ also serves as a co- factor for enzymes, such as the sirtuin and PARP families of enzymes, that modify proteins regulating gene expression, and are involved in DNA repair, inflammation, and innate immune response. Reduced levels of NAD+ are associated with age-related diseases, including metabolic disorder…
Eligibility
- Age range
- 19–60 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Is a non-smoking healthy adult, 19 to 60 years of age, inclusive 2. Has a body mass index (BMI) between 19 and 37.5 kg/m2, inclusive 3. Is free from clinically significant medical problems as determined by the Investigator 4. Is able and willing to provide written informed consent. 5. Is able and willing to provide authorization for the use and disclosure of personal health information in accordance with the Health Insurance Portability and Accountability Act (HIPAA). Exclusion Criteria: 1. Is a current cigarette smoker 2. AST or ALT \> 1.5 times the upper limit of no…
Interventions
- DrugMIB-725
MIB-725 is a modified precursor of the NAD+ biosynthetic pathway.
Location
- Brigham and Women's HospitalBoston, Massachusetts