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This will be a double-blind, randomized, placebo-controlled, single ascending dose, Phase I study in healthy male subjects.
Single oral doses of AKB-4924 will be investigated in up to 6 sequential cohorts of 8 healthy male subjects. Primarily 6 dose levels are planned; the proposed doses are 20 mg, 60 mg, 120 mg, 240 mg, 360 mg, and 480 mg. Actual doses may be decreased or increased based on the safety and tolerability of the drug, as determined by the Investigator and Sponsor. Additional cohorts may be added as needed to test lower, higher, or repeat doses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental:Cohort 1-6 Experimental | Experimental | Intervention AKB 4924 Six subjects per cohort will receive single doses of 20 to up to 480 mg of AKB 4924 orally in a dose escalation format |
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| Placebo:Cohort 1-6 | Placebo Comparator | Intervention Placebo: Two subjects per cohort will receive single oral doses of placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AKB-4924 | Drug | Comparison of different dosages of AKB-4924 |
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| Measure | Description | Time Frame |
|---|---|---|
| Single ascending dose (SAD): Safety and tolerability of AKB-4924 | Safety evaluation will study the adverse event (AE) profile, clinical laboratory safety tests, vital signs and ECG monitoring | 8 days after a single oral dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael McDonnell, MD | Syneos Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| INC Research | Toronto | Canada |
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| ID | Term |
|---|---|
| C575838 | AKB-4924 |
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| Placebo | Other | Placebo comparator |
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