Testing MIB-725 in healthy adults
A Phase 1, Single Ascending Dose Administration of MIB-725 to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Community Dwelling Healthy Adults
This study is testing a new drug called MIB-725 in healthy adults to see if it is safe and could help prevent age-related diseases like kidney injury.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 19 Years to 60 Years |
| Sex | All |
| Sponsor | Metro International Biotech, LLC Industry-sponsored |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06815991 on ClinicalTrials.gov |
What this trial studies
This is a Phase 1 clinical trial designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of MIB-725, a modified precursor in the NAD+ biosynthetic pathway, in healthy adults. The study will involve administering single ascending doses of MIB-725 to participants and monitoring various health parameters, including vital signs and laboratory tests. The trial aims to gather data that could support the development of MIB-725 for preventing age-related diseases, particularly acute kidney injury in at-risk populations.
Who should consider this trial
Good fit: Ideal candidates for this study are non-smoking healthy adults aged 19 to 60 with a BMI between 19 and 37.5 kg/m2.
Not a fit: Patients with significant medical problems, diabetes, or those currently using certain medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new therapeutic strategies for preventing age-related conditions by boosting NAD+ levels in the body.
How similar studies have performed: While this approach is novel, there is growing interest in NAD+ boosters, and preliminary studies have shown potential benefits in related areas.
Eligibility criteria
Show full inclusion / exclusion criteria
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 normal 3. Hematocrit \< 37% or \> 51% 4. Diagnosis of diabetes mellitus, as indicated by use of diabetes medication, hemoglobin A1C \> 6.4% or fasting glucose ≥126 mg/dL 5. Serum creatinine \> 2.0 mg/dL 6. Current use of barbiturates, benzodiazepines, opiates, amphetamine, cannabinoids and cocaine 7. Known allergy to niacin or nicotinamide mononucleotide 8. Unwilling to refrain from drinking alcohol during the duration of the study 9. Use of any other dietary supplement during the course of the trial 10. Use of anabolic steroids, rhGH, DHEA, androstenedione, or any other performance enhancing drug 11. In the judgment of the study physician, the participant is unlikely to comply with the study protocol for any reason or it may not be safe to administer the study medication 12. Has a history of myocardial infarction, stroke, or heart failure in the preceding 6 months. 13. Has a history of cancer other than nonmelanotic skin cancer requiring treatment in the previous 2 years. 14. Has other medical conditions which, in the opinion of the Principal Investigator, would jeopardize the safety of the study subject or impact the validity of the study results. In addition, female participants must: 1. Be postmenopausal as indicated by cessation of menstruation at least one year before screening 2. Not be pregnant and not planning to become pregnant over the next 6 months Prohibited medications and substances: 1. Current use of barbiturates, benzodiazepines, opiates, amphetamine, cannabinoids and cocaine 2. Use of any other dietary supplement during the course of the trial. Subjects who are using a supplement containing nicotinamide, niacin, nicotinamide mononucleotide, or nicotinamide riboside may be included if they agree to stop the supplement at least 2 weeks prior to day 0 and during the entire duration of the study. 3. Initiation of a new prescription drug during the preceding 4 weeks or during the course of the study 4. Use of anabolic steroids, rhGH, DHEA, androstenedione, or any other performance enhancing drug \-
Where this trial is running
Boston, Massachusetts
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Shalender Bhasin, MB, BS — Brigham and Women's Hospital
- Study coordinator: Nancy K Latham, PhD
- Email: nklatham@bwh.harvard.edu
- Phone: 617-999-9195
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.