MH-001 Safety Study in Healthy Volunteers

Overseen By Cynthia Cardinal, Msc, PharmD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Vespina Lifesciences Inc.

Disqualifiers: Cardiovascular, Hepatic, Respiratory, others

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

64 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

First-in-Human study to demonstrate the safety and tolerability of single- and multiple-ascending doses of MH-001 in Healthy Volunteers (HVs)

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the study is for healthy volunteers with no significant medical conditions, it's likely that participants should not be on any regular medications.

What safety data exists for MH-001 or similar treatments in healthy volunteers?

The safety of treatments in healthy volunteers has been studied extensively, with minor adverse effects reported in about 6-7% of cases, and more serious effects being very rare. Studies suggest that the risk involved in these trials is very small, and no lasting negative effects have been reported. ^{1 2 3 4 5}

What makes the drug MH-001 unique compared to other treatments?

The drug MH-001 is being tested in a safety study with healthy volunteers using a microdose approach, which allows for early assessment of how the drug is processed in the human body without significant risk. This method aims to reduce reliance on animal testing and improve the selection of drug candidates by providing early human data on pharmacokinetics (how the drug moves through the body) and metabolism. ^{2 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for healthy volunteers who want to help test a new medication called MH-001. The study will look at how the body processes the drug and its safety. There are specific requirements to join, but they aren't listed here.

Inclusion Criteria

I am a non-smoking male or female not able to bear children, with a healthy weight and normal red blood cell count.

I am in good health with no major illnesses.

Exclusion Criteria

Clinically significant abnormal laboratory test results or positive hepatitis panel and/or positive human immunodeficiency virus test

I have a history of significant skin conditions.

I currently have or recently had gum or teeth problems.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive single and multiple ascending doses of MH-001 or placebo

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MH-001

Trial Overview The study is testing MH-001 by giving it in single doses that increase over time, then multiple doses that also increase. Some people will get a placebo instead of MH-001 to compare effects.

How Is the Trial Designed?

Group I: MH-001 Experimental Treatment 1 Intervention

In each cohort, 6/8 participants will be exposed to 1 or multiple administrations of a specific dosage of MH-001

Group II: Placebo Placebo Group 1 Intervention

In each cohort, 2/8 participants will be exposed to 1 or multiple administrations of a placebo

Who Is Running the Clinical Trial?

Vespina Lifesciences Inc.

Lead Sponsor

Trials

1

Recruited

60+

Syneos Health

Collaborator

Trials

181

Recruited

69,600+

PrimeVigilance Ltd., UK

Industry Sponsor

Trials

4

Recruited

140+

Published Research Related to This Trial

In a comprehensive review of 54 phase-I studies involving 1015 healthy volunteers over 10 years, the overall incidence of adverse events was found to be 12.8%, with a higher rate for active drugs (13.7%) compared to placebo (7.9%).

Most adverse events were minor, with only 3% classified as severe, and no deaths or life-threatening events reported, highlighting that while adverse events are common in phase-I trials, they are typically not serious.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in phase-I studies: a report in 1015 healthy volunteers. Sibille, M., Deigat, N., Janin, A., et al.[2019]

The workshop highlighted the potential of using very low dose human studies (microdoses) to assess drug candidates earlier in the development process, which could improve the selection of effective drugs while ensuring volunteer safety.

Incorporating advanced techniques like accelerator mass spectrometry (AMS) and positron emission tomography (PET) in these early human studies could provide valuable data on how drugs are processed in the body, potentially reducing reliance on animal testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early microdose drug studies in human volunteers can minimise animal testing: Proceedings of a workshop organised by Volunteers in Research and Testing. Combes, RD., Berridge, T., Connelly, J., et al.[2019]

In a survey of 459 members of the British Pharmacological Society, it was found that drugs were administered to 8163 healthy volunteers, with only 6.9% experiencing minor adverse effects and 0.04% facing potentially life-threatening effects, indicating a very low risk associated with these studies.

Among 7607 healthy student volunteers, only 6.0% reported minor adverse effects during drug administration for educational purposes, with no severe adverse effects noted, reinforcing the overall safety of drug administration in healthy volunteer studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Healthy volunteer studies in Great Britain: the results of a survey into 12 months activity in this field. Orme, M., Harry, J., Routledge, P., et al.[2019]

In a review of 109 clinical studies with 1228 healthy volunteers, 19% reported adverse events during placebo administration, highlighting that even without active treatment, participants can experience side effects.

Adverse events were more common with repeated dosing (28%) and among elderly participants (26%), with headaches, drowsiness, and asthenia being the most frequently reported issues, indicating that placebo effects can significantly influence safety evaluations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The placebo effect in healthy volunteers: influence of experimental conditions on the adverse events profile during phase I studies. Rosenzweig, P., Brohier, S., Zipfel, A.[2023]

In a review of 24 First-in-Man studies involving 1,017 healthy male volunteers, the incidence of adverse events (AEs) was low, with 98.3% of AEs being mild or moderate, indicating a favorable safety profile for small molecules in Phase I trials.

Only 0.4% of treatments resulted in serious adverse events, all of which were not medically concerning and did not require hospitalization, suggesting that small molecule trials can be conducted safely in healthy volunteers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety of healthy volunteers in First-in-Man trials - an analysis of studies conducted at the Bayer in-house ward from 2000 to 2005. Wensing, G., Ighrayeb, IA., Boix, O., et al.[2019]

In a review of 22 First-in-Human trials involving 1,250 healthy volunteers, the overall risk of severe adverse events (AEs) was low, with only 0.4% of subjects experiencing serious AEs related to the active drug or procedure.

Participants receiving active treatment experienced a higher incidence of AEs compared to those on placebo, with 88.2% of reported AEs being mild, indicating that while there are risks, most side effects were not severe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How safe are our studies? Analysis of adverse events in Bayer First-in-Human trials from 2006 to 2016 . Jung, D., Boettcher, MF., Wensing, G.[2020]

Pre-clinical studies in animals cannot be directly applied to humans, highlighting the necessity for thorough pre-therapeutical studies to understand how new drugs are absorbed, distributed, metabolized, and excreted (ADME) in humans.

Safety is the top priority in human clinical trials, which must follow approved protocols and be monitored closely, yet there are legal and ethical challenges in conducting studies with healthy volunteers in France, necessitating clearer legislation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Current practice of drug trials in healthy volunteers]. Duchier, J.[2007]

The study analyzed starting doses in first-in-human (FIH) trials and found that they have often been set too conservatively, potentially hindering effective drug development.

By applying a reasonable safety factor based on no-observed adverse-effect levels (NOAELs) from nonclinical studies, it may be possible to establish starting doses that balance safety with the need for effective drug testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Investigation of the relationship between a starting dose in first-in-human studies and no observed adverse effect level in nonclinical studies. Sato, A., Narukawa, M.[2014]

Citations

1. Germany pubmed.ncbi.nlm.nih.gov

Adverse events in phase-I studies: a report in 1015 healthy volunteers. [2019]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Early microdose drug studies in human volunteers can minimise animal testing: Proceedings of a workshop organised by Volunteers in Research and Testing. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Healthy volunteer studies in Great Britain: the results of a survey into 12 months activity in this field. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

The placebo effect in healthy volunteers: influence of experimental conditions on the adverse events profile during phase I studies. [2023]

5. Germany pubmed.ncbi.nlm.nih.gov

The safety of healthy volunteers in First-in-Man trials - an analysis of studies conducted at the Bayer in-house ward from 2000 to 2005. [2019]

6. Germany pubmed.ncbi.nlm.nih.gov

How safe are our studies? Analysis of adverse events in Bayer First-in-Human trials from 2006 to 2016 . [2020]

7. France pubmed.ncbi.nlm.nih.gov

[Current practice of drug trials in healthy volunteers]. [2007]

8. Germany pubmed.ncbi.nlm.nih.gov

Investigation of the relationship between a starting dose in first-in-human studies and no observed adverse effect level in nonclinical studies. [2014]