MIB-725 Safety Study

Overseen By Mary F Weiss

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Metro International Biotech, LLC

Must not be taking: Barbiturates, Benzodiazepines, Opiates, others

Disqualifiers: Diabetes, Cancer, Heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 25

Duration: 1 day

32 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and tolerability of MIB-725, a new oral treatment, in healthy adults. Researchers will administer single doses of the drug in increasing amounts to observe the body's reactions. They will check for side effects through various health tests, such as blood work and heart monitoring. Participants should be non-smoking, healthy adults without any major medical problems.

As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding how it works in people.

Will I have to stop taking my current medications?

You may need to stop taking certain medications and supplements to participate in this trial. Specifically, you cannot use barbiturates, benzodiazepines, opiates, amphetamines, cannabinoids, cocaine, or any dietary supplements during the study. If you are taking a supplement with nicotinamide or similar ingredients, you must stop at least 2 weeks before the study starts.

Is there any evidence suggesting that MIB-725 is likely to be safe for humans?

Research has shown that MIB-725 is a new drug undergoing testing to determine its safety. Currently, specific safety information for MIB-725 is limited. This trial is in an early stage, focusing primarily on assessing the drug's safety. In such trials, researchers administer increasing doses to observe any side effects.

The study will monitor changes in blood tests, heart function (using an EKG), and other vital health indicators. If MIB-725 had prior approval for other uses, it might suggest general safety, but that is not the case here. As a new drug, data from this trial will reveal how well participants tolerate it and identify any potential side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

MIB-725 is unique because it offers a novel approach by delivering treatment in a single oral dose, with doses ranging from 100 mg to 800 mg. Unlike standard treatments that often involve multiple doses or intravenous administration, MIB-725's oral route could enhance patient convenience and adherence. Researchers are particularly excited about its potential to maintain effectiveness while simplifying the treatment process, potentially reducing side effects associated with more complex dosing regimens.

What evidence suggests that MIB-725 could be effective?

Research has shown that MIB-725 is a promising new treatment that boosts NAD, a crucial molecule aiding in energy production and cellular repair. Early lab studies found that MIB-725 can increase NAD levels, potentially supporting cell health and longevity. Although data from human studies remains limited, the initial lab results are encouraging. This trial tests MIB-725 in a single-dose ascending study to confirm these benefits in people. ^{2 4 6 7 8}

Who Is on the Research Team?

Shalender Bhasin, MB, BS

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

This clinical trial is open to healthy adults who can participate in a study assessing the safety of a new drug called MIB-725. Participants will be part of one of four groups, each receiving different doses of the medication.

Inclusion Criteria

I am not pregnant and do not plan to become pregnant in the next 6 months.

I am a healthy adult aged 19-60 and I do not smoke.

Free from clinically significant medical problems as determined by the Investigator

Exclusion Criteria

Known allergy to niacin or nicotinamide mononucleotide

Serum creatinine > 2.0 mg/dL

Current cigarette smoker

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Treatment

Participants receive a single ascending dose of MIB-725 (100, 200, 400, or 800 mg) to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics

1 day

1 visit (in-person) for administration and observation

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments including blood sampling and observation

4 weeks

Visits at 24 hours, 48 hours, and on Days 5, 7, 14, and 28

What Are the Treatments Tested in This Trial?

Interventions

• MIB-725

Trial Overview The trial is testing single increasing doses (100, 200, 400, and 800 mg) of MIB-725 to see how safe it is and how the body reacts to it. It's an open-label study where everyone knows what treatment they're getting.

How Is the Trial Designed?

Group I: Safety and pharmacokinetic single dose ascending dose study Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Metro International Biotech, LLC

Lead Sponsor

Trials

5

Recruited

230+

Published Research Related to This Trial

Only 27 out of 100 newly approved pharmaceuticals had specific toxicology data available at the time of their approval, highlighting a significant gap in safety information for healthcare providers.

There was an average delay of 27.4 months for labeling revisions to include updated toxicology information, which can hinder effective treatment for patients experiencing adverse drug reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of pharmaceutical labeling for overdose treatment and toxicity data. Mazer-Amirshahi, M., Sokol, G., van den Anker, J., et al.[2013]

The STEP database is a new resource that compiles safety and toxicity data for excipients used in pediatric formulations, addressing the need for accessible and organized information that is often scattered across various sources.

Currently containing data from over 2000 references on 10 excipients, the database allows users to search for and by excipients, making it a unique tool for researchers and developers in ensuring the safety of pediatric medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The STEP (Safety and Toxicity of Excipients for Paediatrics) database: part 2 - the pilot version. Salunke, S., Brandys, B., Giacoia, G., et al.[2022]

The safety of marketed drugs is a significant concern, as some commonly prescribed medications can lead to serious or life-threatening side effects in patients.

The ChEMBL resource will provide a curated drug safety data set, including toxicity classifications and black box warnings, which will be freely available and regularly updated to aid in drug safety research and discovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug Safety Data Curation and Modeling in ChEMBL: Boxed Warnings and Withdrawn Drugs. Hunter, FMI., Bento, AP., Bosc, N., et al.[2023]

In a pooled analysis of 19 clinical trials involving 4,435 patients treated with tiotropium, the drug significantly reduced the risk of dyspnea and COPD exacerbations compared to placebo, indicating its efficacy in managing obstructive lung disease.

However, tiotropium was associated with a higher risk of dry mouth and urinary retention, highlighting the importance of monitoring these side effects in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pooled clinical trial analysis of tiotropium safety. Kesten, S., Jara, M., Wentworth, C., et al.[2015]

The Drug Adverse Reaction Database (DART) provides detailed information on 147 confirmed and 89 potential protein targets associated with adverse drug reactions (ADRs), which is crucial for understanding the mechanisms behind these reactions and aiding in drug discovery.

DART includes extensive data on 257 drugs and 1080 ligands, offering insights into their binding properties, physiological functions, and the specific adverse effects they may cause, making it a valuable resource for researchers and developers in pharmacology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug Adverse Reaction Target Database (DART) : proteins related to adverse drug reactions. Ji, ZL., Han, LY., Yap, CW., et al.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06815991

Phase 1a Single Ascending Dose Study of MIB-725 in ... Towards this long- term goal, the proposed Phase 1 trial will determine the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple ...

2. withpower.com withpower.com/trial/mib-725-safety-study-b0f27

MIB-725 Safety Study This Phase 1 medical study run by Metro International Biotech, LLC is evaluating whether MIB-725 will have tolerable side effects & efficacy for patients with

3. biospace.com biospace.com/press-releases/metro-international-biotech-announces-initial-dosing-in-the-first-cohort-of-a-phase-1a-clinical-trial-of-its-novel-nad-booster-mib-725

Metro International Biotech Announces Initial Dosing in the ... MIB-725 is a new, proprietary investigational drug that has been demonstrated in preclinical studies to be a potent NAD precursor or booster.

4. rally.massgeneralbrigham.org rally.massgeneralbrigham.org/search?q=Safety%20Issues

Rally - Search - Safety Issues We are doing this study to help find out the blood levels of MIB-725 and its metabolites (products derived from its processing by the human body) over time.

5. linkedin.com linkedin.com/posts/davidsinclairphd_metro-international-biotech-announces-initial-activity-7320768659264593923-7h4G

Metro starts Phase 1 testing of NAD booster drug MIB-725 has shown strong potential in boosting NAD in early (preclinical) lab studies. • Currently in early human testing (Phase 1a): ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06815991

Phase 1a Single Ascending Dose Study of MIB-725 in ... The progression to a higher dose level requires review of the safety data from the entire cohort up to 7 days after the dose by the Safety Review Committee.

7. rally.massgeneralbrigham.org rally.massgeneralbrigham.org/study/a_phase_1_dose_admin

A Phase 1 Dose Administration of MIB-725 in Community ... In this study, we want to find out if this oral study medication, MIB-725, is safe to take at different dose levels without causing many side effects. This ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10721522/

The Safety and Antiaging Effects of Nicotinamide ... However, on 10 November, 2022, the US Food and Drug Administration (FDA) declared that β-NMN is prohibited as a health supplement. Metro International Biotech ...