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The study will assess the safety, tolerability and fecal shedding of STP206 when given as a single dose and when given as daily doses for one week.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| STP206 | Experimental | STP206 administered either as a single dose or as a daily dose for seven consecutive days |
|
| Vehicle Control | Placebo Comparator | STP206 vehicle administered as either a single dose or as a daily dose for 7 consecutive days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STP206 or vehicle control | Drug | STP206 or vehicle administered as either a single dose or as a daily dose for 7 consecutive days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | 7-days post dosing and 30-days post dosing | |
| Changes in physical examination findings | 7-days post dosing | |
| Changes in laboratory (hematology, chemistry, and urinalysis) variables | 7-days post dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Fecal Shedding of STP206 components | 30 days post dosing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Taha Keilani, MD | Leadiant Biosciences, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SNBL Clinical Pharmacology Center, Inc. | Baltimore | Maryland | 21201 | United States |
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