First-in-Human study to demonstrate the safety and tolerability of single- and multiple-ascending doses of MH-001 in Healthy Volunteers (HVs)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
58
Syneos Health clinic
Québec, Quebec, Canada
Percentage of participants with treatment-emergent adverse events (TEAEs)
Percentage of participants with treatment-emergent adverse events (TEAEs)
Time frame: 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
Area under the concentration-time curve (AUC) of the analyte in plasma over time
Time frame: 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
Time frame: 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
Time frame: 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
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