Evaluating the safety and tolerability of MH-001 in healthy volunteers
A Two-Part Randomized Double-Blinded Placebo-Controlled, Phase 1 Study of Single and Multiple Ascending Doses of MH-001 in Healthy Participants
This study is testing a new drug called MH-001 in healthy volunteers to see how it works in the body and if it’s safe to use.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Vespina Lifesciences Inc. Industry-sponsored |
| Locations | 1 site (Quebec) |
| Trial ID | NCT06780254 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the pharmacokinetics, safety, and tolerability of MH-001 through single- and multiple-ascending doses administered to healthy volunteers. It is a first-in-human trial designed to gather essential data on how the drug behaves in the body and its potential side effects. Participants will receive either the drug or a placebo, and their health will be closely monitored throughout the study. The findings will help determine the appropriate dosing and safety profile for future studies.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy male or non-childbearing potential female volunteers with a BMI between 18.5 and 32.0 kg/m².
Not a fit: Patients with a history of significant medical illnesses or those with clinically significant laboratory abnormalities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical safety and dosing information for MH-001, paving the way for its use in treating various conditions.
How similar studies have performed: Other first-in-human studies have shown success in establishing safety and pharmacokinetics for new drugs, making this approach a standard practice in drug development.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or non-childbearing potential Female, non smoker, with a Body Mass Index (BMI) between 18.5 and 32.0 kilogram per meter square (kg/m2) and red blood cells greater or equal (≥) to 120 grams per liter (g/L) for women and ≥135 g/L for men * In good health, determined by no clinically significant findings of skin, dental, neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease Exclusion Criteria: * Have a history or presence of clinically significant medical illness including, but not limited to, any cardiovascular, hepatic, respiratory, hematological, chronic or relevant acute infections, relevant immunodeficiency, renal, endocrine, psychiatric or neurological disease, or any clinically significant laboratory abnormality that, in the judgment of the Investigator, indicates a medical problem that would preclude study participation. * History of skin disorders including clinically significant active skin disease. * History/signs and symptoms of current or recurrent teeth and gums disease * Clinically significant abnormal laboratory test results or positive hepatitis panel and/or positive human immunodeficiency virus test.
Where this trial is running
Quebec
- Syneos Health clinic — Quebec, Canada (Recruiting)
Study contacts
- Study coordinator: Cynthia Cardinal, Msc, PharmD
- Email: cynthia.cardinal@vespinalifesciences.com
- Phone: 1-514-452-9046
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.