Clinical trial NCT06780254: A Study to Evaluate the Pharmacokinetics (PK), Safety and Tolerability of Single- and Multiple-Ascending Doses of MH-001 in Healthy Volunteers
Official title: A Two-Part Randomized Double-Blinded Placebo-Controlled, Phase 1 Study of Single and Multiple Ascending Doses of MH-001 in Healthy Participants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy Volunteers
First In Human
Safety
Tolerability
Pharmacokinetics
Pharmacodynamics
Lead sponsor: Vespina Lifesciences Inc.
Sponsor class: INDUSTRY
Collaborators: name: Syneos Health
name: PrimeVigilance Ltd., UK
First posted: 2025-01-17
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: SAD: Single Ascending Dose, 5 cohorts of different dosages versus placebo MAD: Multiple Ascending Dose, 3 cohorts of different dosages versus placebo
Primary purpose: BASIC_SCIENCE

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)


Eligibility 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.

Primary outcomes:
measure: Percentage of participants with treatment-emergent adverse events (TEAEs)
timeFrame: 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:
measure: Area under the concentration-time curve (AUC) of the analyte in plasma over time
timeFrame: 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
measure: Peak Plasma Concentration (Cmax) of the analyte in plasma
timeFrame: 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
measure: Time to reach Peak Concentration (Tmax) of the analyte in plasma
timeFrame: 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
Other outcomes:
Locations:
city: Quebec
country: Canada
facility: Syneos Health clinic
Study officials:
References: