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The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of single-ascending and multiple-ascending doses of ALZ002 DS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALZ002 DS | Experimental | SAD: 6 cohorts of subjects are planned to be orally dosed, ranging from 15 mg - 800 mg. MAD: 3 cohorts of subjects are planned to be orally dosed once or twice daily for 7 consecutive days, ranging from 300 mg - 600 mg. |
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| Placebo | Placebo Comparator | Placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALZ002 DS | Drug | Administered orally |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of SAEs and treatment-related adverse events | Incidence of SAEs and treatment-related severe AEs | Baseline through Study Completion (up to Day 14) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) will be assessed | Maximum observed plasma concentration (Cmax) | predose, 0.5, 1, 2, 4, 8, 12, 16, and 24 hours postdose; Day 3: predose; Day 4:predose; Day 5:predose; Day 6: predose; Day7: predose, 0.5, 1, 2, 4, 8, 12, 16, and 24 hours postdose |
| Area Under the Curve (AUC) will be assessed |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cmax clinical research | Adelaide | 5000 | Australia |
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| Placebo |
| Drug |
Administered orally |
|
Area under the plasma concentration versus time curve |
| predose, 0.5, 1, 2, 4, 8, 12, 16, and 24 hours postdose; Day 3: predose; Day 4:predose; Day 5:predose; Day 6: predose; Day7: predose, 0.5, 1, 2, 4, 8, 12, 16, and 24 hours postdose |