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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06780254

Enrollment

Registered

2025-01-17

Start date

2024-09-09

Completion date

2025-06-26

Last updated

2026-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

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

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)

Interventions

DRUGMH-001

capsules

DRUGPlacebo

capsules

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

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

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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	Percentage of participants with treatment-emergent adverse events (TEAEs)

Secondary

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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026