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| Name | Class |
|---|---|
| Syneos Health | OTHER |
| PrimeVigilance Ltd., UK | INDUSTRY |
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First-in-Human study to demonstrate the safety and tolerability of single- and multiple-ascending doses of MH-001 in Healthy Volunteers (HVs)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MH-001 | Experimental | In each cohort, 6/8 participants will be exposed to 1 or multiple administrations of a specific dosage of MH-001 |
|
| Placebo | Placebo Comparator | In each cohort, 2/8 participants will be exposed to 1 or multiple administrations of a placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MH-001 | Drug | capsules |
| |
| Placebo |
| 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Syneos Health clinic | Québec | Quebec | G1P 0A2 | Canada |
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SAD: Single Ascending Dose, 4 cohorts of different dosages versus placebo MAD: Multiple Ascending Dose, 3 cohorts of different dosages versus placebo
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| Drug |
capsules |
|
| 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 |