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

NCT06815991 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: MIB-725-101
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Keywords

Phase 1; NAD Booster

Outcome Measures

Primary Outcomes (2)

• Treatment-emergent adverse events

  Any treatment-emergent adverse events, including any ocular adverse events

  Baseline to 28 days

• Treatment-emergent serious adverse events

  Treatment-emergent serious adverse events, including any severe or serious ocular adverse events

  Baseline to 28 days

Secondary Outcomes (14)

• Change in blood pressure

  Baseline to 28 days

• Change in heart rate

  Baseline to 28 days

• Presence of conjunctival injection

  Baseline to 28 days

• Change in QTc interval

  Baseline to 28 days

• Pharmacokinetics

  Baseline to 28 days

Other Outcomes (6)

• changes in insulin sensitivity

  Baseline to 28 days

• Change in total cholesterol

  Baseline to 28 days

• Changes from baseline in triglyceride

  Baseline to 28 days

Study Arms (1)

Safety and pharmacokinetic single dose ascending dose study

EXPERIMENTAL

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

Drug: MIB-725

Interventions

MIB-725 DRUG

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

Safety and pharmacokinetic single dose ascending dose study

Eligibility Criteria

• Age: 19 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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:

Sponsors & Collaborators

• Metro International Biotech, LLC: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Study Officials

• Shalender Bhasin, MB, BS

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nancy K Latham, PhD

CONTACT

617-999-9195; nklatham@bwh.harvard.edu

Mary F Weiss

CONTACT

mweiss2@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: Because this is a phase one ascending dose study, masking is not possible.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a single ascending dose study in which 4 different doses of MIB-725 will be administered in ascending order starting with the lowest dose.

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: February 10, 2025
• Study Start: February 11, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)