A Study to Evaluate the Pharmacokinetics (PK), Safety and Tolerability of Single- and Multiple-Ascending Doses of MH-001 in Healthy Volunteers

NCT06780254 | Completed Phase 1 DMC

• 1 other identifier: MH001-01
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

Healthy Volunteers; First In Human; Safety; Tolerability; Pharmacokinetics; Pharmacodynamics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (2)

MH-001

EXPERIMENTAL

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

Drug: MH-001

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

MH-001 DRUG

capsules

MH-001

Placebo DRUG

capsules

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vespina Lifesciences Inc.: lead
• Syneos Health: collaborator
• PrimeVigilance Ltd., UK: collaborator

Study Sites (1)

Syneos Health clinic

Québec, Quebec, G1P 0A2, Canada

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: SAD: Single Ascending Dose, 4 cohorts of different dosages versus placebo MAD: Multiple Ascending Dose, 3 cohorts of different dosages versus placebo

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: January 17, 2025
• Study Start: September 9, 2024
• Primary Completion: May 29, 2025
• Study Completion: June 26, 2025
• Last Updated: March 3, 2026

Record last verified: 2026-02

Locations

CA (1)