Actively Recruiting

Phase 1
Age: 19Years - 60Years
All Genders
Healthy Volunteers
NCT06815991

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

Led by Metro International Biotech, LLC · Updated on 2026-02-19

32

Participants Needed

1

Research Sites

106 weeks

Total Duration

On this page

AI-Summary

What this Trial 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 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

Official Title

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

Who Can Participate

Age: 19Years - 60Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Non-smoking healthy adults aged 19 to 60 years inclusive
  • Body mass index (BMI) between 19 and 37.5 kg/m2 inclusive
  • Free from clinically significant medical problems as determined by the Investigator
  • Able and willing to provide written informed consent
  • Able and willing to provide authorization for use and disclosure of personal health information according to HIPAA
Not Eligible

You will not qualify if you...

  • Current cigarette smoker
  • AST or ALT greater than 1.5 times the upper limit of normal
  • Hematocrit less than 37% or greater than 51%
  • Diagnosis of diabetes mellitus indicated by use of diabetes medication, hemoglobin A1C over 6.4%, or fasting glucose 126 mg/dL or higher
  • Serum creatinine greater than 2.0 mg/dL
  • Current use of barbiturates, benzodiazepines, opiates, amphetamine, cannabinoids, or cocaine
  • Known allergy to niacin or nicotinamide mononucleotide
  • Unwilling to refrain from drinking alcohol during the study
  • Use of any other dietary supplement during the trial
  • Use of anabolic steroids, rhGH, DHEA, androstenedione, or other performance enhancing drugs
  • Unlikely to comply with study protocol or unsafe to administer study medication as judged by the physician
  • History of myocardial infarction, stroke, or heart failure in the preceding 6 months
  • History of cancer other than nonmelanotic skin cancer treated within the previous 2 years
  • Other medical conditions that could jeopardize safety or study validity as judged by the Principal Investigator
  • Female participants must be postmenopausal for at least one year, not pregnant, and not planning pregnancy for 6 months
  • Initiation of new prescription drugs within 4 weeks before or during the study

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

Actively Recruiting

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Research Team

N

Nancy K Latham, PhD

CONTACT

M

Mary F Weiss

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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