Recruiting
Phase 1

MIB-725

Sponsor:

Metro International Biotech, LLC

Code:

NCT06815991

Conditions

Healthy Adults

Eligibility Criteria

Sex: All

Age: 19 - 60

Healthy Volunteers: Accepted

Interventions

MIB-725

Study Details

Brief 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.

Conditions

Healthy Adults

Study ID

NCT06815991

Start date

Feb 11, 2025

Status verified date

Feb, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19 - 60

Healthy Volunteers: Accepted

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

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Study Design

Enrollment

32 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

MIB-725

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Principal Investigator:

Shalender Bhasin, MB, BS

More Information

Sponsor

Metro International Biotech, LLC

Last update posted

Feb 19, 2026

Last verified

Feb, 2026

Keywords

  • Phase 1
  • NAD Booster

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Metro International Biotech, LLC on 2026-02-19.