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The study is a randomized, double-blind, placebo-controlled, single and multiple ascending dose study to assess the safety and tolerability of COR588 HCl in healthy male and female subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COR588 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COR588 | Drug | Increasing doses of COR588 will be administered for cohorts 1-4 in the single ascending dose phase and for cohorts 1-4 in the multiple ascending dose phase. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment emergent adverse events. | Assessment of the incidence and severity of treatment-emergent adverse events. | Through Day 8 for the single ascending dose phase and through Day 19 for the multiple ascending dose phase. |
| Changes in chemistry lab measures (Sodium [Na], Blood Urea Nitrogen [BUN], Calcium [Ca], Total bilirubin). | Assessment of changes in serum chemistry measures. | Through Day 8 for the single ascending dose phase and through Day 19 for the multiple ascending dose phase. |
| Changes in hematology lab measures (red blood cell count [RBC], hemoglobin [Hgb], hematocrit [Hct]). | Assessment of changes in hematology measures. | Through Day 8 for the single ascending dose phase and through Day 19 for the multiple ascending dose phase. |
| Changes in urinalysis lab parameters (pH, specific gravity, glucose). | Assessment of changes in urinalysis parameters. | Through Day 8 for the single ascending dose phase and through Day 19 for the multiple ascending dose phase. |
| Measure | Description | Time Frame |
|---|---|---|
| AUC | Area under the concentration-time curve | To Day 3 for the single ascending dose phase and to Day 11 for the multiple ascending dose phase. |
| Cmax | Maximum observed drug concentration during a dosing interval |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nucleus Network Pty Ltd | Melbourne | Victoria | Australia |
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| Placebo | Drug | Placebo will be administered for cohorts 1-4 in the single ascending dose phase and for cohorts 1-4 in the multiple ascending dose phase. |
|
| To Day 3 for the single ascending dose phase and to Day 11 for the multiple ascending dose phase. |
| Tmax | Time to Cmax | To Day 3 for the single ascending dose phase and to Day 11 for the multiple ascending dose phase. |