A Study to Evaluate the Pharmacokinetics (PK), Safety and Tolerability of Single- and Multiple-Ascending Doses 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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: MH-001

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Québec, Quebec, Canada, G1P 0A2
      • Syneos Health clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MH-001; In each cohort, 6/8 participants will be exposed to 1 or multiple administrations of a specific dosage of MH-001	Drug: MH-001; capsules
Placebo Comparator: Placebo; In each cohort, 2/8 participants will be exposed to 1 or multiple administrations of a placebo	Drug: Placebo; capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants with treatment-emergent adverse events (TEAEs)	Percentage of participants with treatment-emergent adverse events (TEAEs)	SAD: From day of dosing until 15 days after drug administration; MAD: From first day of dosing up to 28 days after the last day (Day 28) of study drug administration

Secondary Outcome Measures

Outcome Measure	Time Frame
Area under the concentration-time curve (AUC) of the analyte in plasma over time	SAD: Pre-dose and at multiple timepoints post-dose on Days 1 to 15; MAD: Pre-dose and at multiple timepoints post-dose on Days 1 to 56
Peak Plasma Concentration (Cmax) of the analyte in plasma	SAD: Pre-dose and at multiple timepoints post-dose on Days 1 to 15; MAD: Pre-dose and at multiple timepoints post-dose on Days 1 to 56
Time to reach Peak Concentration (Tmax) of the analyte in plasma	SAD: Pre-dose and at multiple timepoints post-dose on Days 1 to 15; MAD: Pre-dose and at multiple timepoints post-dose on Days 1 to 56

Collaborators and Investigators

• Sponsor: Vespina Lifesciences Inc.
• Collaborators: Syneos Health; PrimeVigilance Ltd., UK

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2024
• Primary Completion (Actual): May 29, 2025
• Study Completion (Actual): June 26, 2025

Study Registration Dates

• First Submitted: January 7, 2025
• First Submitted That Met QC Criteria: January 14, 2025
• First Posted (Actual): January 17, 2025

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: February 27, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Safety; Pharmacokinetics; Healthy Volunteers; Tolerability; Pharmacodynamics; First In Human
• Other Study ID Numbers: MH001-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No