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This is a single-site, randomized, double-blind, placebo-controlled, multiple dose, flexible dosage range, PK and PD study of SKL15508 as monotherapy in subjects with stable schizophrenia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SKL15508 High Dose | Experimental | SKL15508 High Dose |
|
| SKL15508 Medium Dose | Experimental | SKL15508 Medium Dose |
|
| SKL15508 Low Dose | Experimental | SKL15508 Low Dose |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SKL15508 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number and percent of subjects experiencing an adverse event. | 10 days | |
| Change from baseline in event-related potentials (ERP) following multiple oral doses of SKL15508. | During the course of 10 days | |
| Change from baseline in clinical laboratory assessments. | 10 days | |
| Change from baseline in vital signs. | 10 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Glendale Adventist Medical Center | Glendale | California | 91206 | United States |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| Drug |
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