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This is a double-blind, placebo-controlled, randomized, phase 1 study to evaluate safety, tolerability, and pharmacokinetics of orally administered DA-7503 after single and multiple ascending dose regimens in healthy adult and elderly participants
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [Single dose] DA-7503 | Experimental | 6 subjects in each Cohort(Cohort 1-6) |
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| [Single dose] Placebo | Placebo Comparator | 2 subjects in each Cohort(Cohort 1-6) |
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| [Multiple dose] DA-7503 | Experimental | 6 subjects in each Cohort(Cohort 1-5) |
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| [Multiple dose] Placebo | Placebo Comparator | 2 subjects in each Cohort(Cohort 1-5) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DA-7503 Single dose | Drug | Oral administration for once; Dose strength is different for each cohort(Cohort 1, 2, 3, 4, 5 and 6). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of DA-7503 single dose oral administration | Peak Plasma Concentration of DA-7503 (Cmax) | 5 days |
| Pharmacokinetics of DA-7503 single dose oral administration | Area under the plasma concentration versus time curve of DA-7503 (AUClast) | 5 days |
| Pharmacokinetics of DA-7503 multiple dose oral administration | Peak Plasma Concentration of DA-7503 (Cmax) | 11 days |
| Pharmacokinetics of DA-7503 multiple dose oral administration | Area under the plasma concentration versus time curve of tau (AUCtau) | 11 days |
| Pharmacokinetics of DA-7503 multiple dose oral administration | Peak Plasma Concentration of DA-7503 in steady state (Cmax,ss) | 11 days |
| Pharmacokinetics of DA-7503 multiple dose oral administration | Area under the plasma concentration versus time curve of tau in steady state (AUCtau,ss) | 11 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
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| DA-7503 Multiple dose | Drug | Oral administration once daily for 7 days; Dose strength or target volunteer is different for each cohort(Cohort 1, 2, 3, 4 and 5) |
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| Placebo Single dose | Drug | Oral administraion for once. |
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| Placebo Multiple dose | Drug | Oral administration once daily for 7 days |
|