NCT06815991 · Metro International Biotech, LLC
Phase 1a Single Ascending Dose Study of MIB-725 in Healthy Adults
What this study is about
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 how the drug affects the body of MIB-725 in community dwelling, healthy adults. Up to 4 successive groups (cohorts) of 8 subjects each will be enrolled in this trial.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Is a non-smoking healthy adult, 19 to 60 years of age, inclusive
- Has a body mass index (BMI) between 19 and 37.5 kg/m2, inclusive
- Is free from clinically significant medical problems as determined by the Investigator
- Is able and willing to provide written informed consent.
- 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
- Is a current cigarette smoker
- AST or ALT \> 1.5 times the upper limit of normal
- Hematocrit \< 37% or \> 51%
- Diagnosis of diabetes mellitus, as indicated by use of diabetes medication, hemoglobin A1C \> 6.4% or fasting glucose ≥126 mg/dL
- Serum creatinine \> 2.0 mg/dL
- Current use of barbiturates, benzodiazepines, opiates, amphetamine, cannabinoids and cocaine
- Known allergy to niacin or nicotinamide mononucleotide
- Unwilling to refrain from drinking alcohol during the duration of the study
- Use of any other dietary supplement during the course of the trial
- Use of anabolic steroids, rhGH, DHEA, androstenedione, or any other performance enhancing drug
- 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
- Has a history of myocardial infarction, stroke, or heart failure in the preceding 6 months.
- Has a history of cancer other than nonmelanotic skin cancer requiring treatment in the previous 2 years.
- 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:
- Be postmenopausal as indicated by cessation of menstruation at least one year before screening
- Not be pregnant and not planning to become pregnant over the next 6 months Prohibited medications and substances:
- Current use of barbiturates, benzodiazepines, opiates, amphetamine, cannabinoids and cocaine
- 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.
- Initiation of a new prescription drug during the preceding 4 weeks or during the course of the study
- Use of anabolic steroids, rhGH, DHEA, androstenedione, or any other performance enhancing drug \-
Where
- Boston, Massachusetts
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 19, 2026 · Source of record for eligibility and locations