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

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.

Conditions

Healthy Adults

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

A Phase 1, Single Ascending Dose Administration of MIB-725 to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Community Dwelling Healthy Adults

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

Condition
Healthy Adults
Intervention / Treatment

-

Contacts and Locations

Boston

Brigham and Women's Hospital, Boston, Massachusetts, United States, 02115

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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).
  • 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.
  • 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
  • 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

Ages Eligible for Study

19 Years to 60 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Metro International Biotech, LLC,

Shalender Bhasin, MB, BS, PRINCIPAL_INVESTIGATOR, Brigham and Women's Hospital

Study Record Dates

2025-11