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This is the first study of SRX246 in humans, and is being conducted to begin to establish a safety profile of orally administered SRX246.
This protocol represents the first in human study of SRX246, and is being conducted to begin to establish a safety profile, and collect human tolerability and pharmacokinetic data of orally administered SRX246.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Experimental | Single oral dose of SRX246 capsule |
|
| Placebo | Placebo Comparator | Single oral dose of placebo capsule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SRX246 | Drug | single oral dose of SRX246 capsule |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| To assess safety and tolerability of SRX246 at single doses ranging between 20 and 360 mg | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| To assess Pharmacokinetics of SRX246 at single doses ranging between 20 and 360 mg | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benno G Roesch, MD | Advanced Biomedical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced Biomedical Research | Hackensack | New Jersey | 07601 | United States |
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| ID | Term |
|---|---|
| C584649 | SRX246 |
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| Drug |
Single oral dose of placebo capsule |
|