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

Launched by METRO INTERNATIONAL BIOTECH, LLC · Feb 4, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new medication called MIB-725 to see how safe it is and how the body processes it. The study involves healthy adults aged 19 to 60, who are not smoking and meet specific health criteria. Participants will receive a single dose of MIB-725, with increasing amounts (100, 200, 400, and 800 mg) to help researchers understand how well the drug is tolerated and if there are any side effects.

To be eligible for this trial, participants must not have any significant medical problems, must be willing to stop using certain medications and dietary supplements, and females must be postmenopausal and not planning to become pregnant during the study. Throughout the trial, participants can expect to undergo various health checks, including physical exams, vital signs monitoring, and blood tests, to ensure their safety. This study is a first step in understanding how MIB-725 might be used in future treatments, so your participation could help pave the way for new medical advancements.

Gender

ALL

Eligibility criteria

• 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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