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| ID | Type | Description | Link |
|---|---|---|---|
| WRAIR-2285 | Other Identifier | Walter Reed Army Institute of Research |
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| Name | Class |
|---|---|
| Walter Reed Army Institute of Research (WRAIR) | FED |
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This study will examine the safety of ascending doses of AB-SA01 when topically applied to intact skin of healthy adults.
AB-SA01 consists of three bacteriophages (viruses) that target Staphylococcus aureus bacteria.
The safety of AB-SA01 will be assessed when topically administered once daily to the volar aspect of the forearm at a dose of 10^8 plaque forming units (PFU) per phage for 3 consecutive days, and then at a dose of 10^9 plaque forming units (PFU) per phage for 3 consecutive days. Both AB-SA01 and placebo will be administered to each subject to provide his/her own control for evaluation of skin reactions. The right or left placement of the placebo will be randomized and double-blinded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 10^8 | Experimental | AB-SA01 (10^8) and Placebo |
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| Cohort 10^9 | Experimental | AB-SA01 (10^9) and Placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AB-SA01 (10^8 PFU per phage) | Biological | Gauze pads will be saturated with AB-SA01 and then applied to each subject's volar forearm and covered with occlusive dressing once daily for 3 consecutive days. Placement of the gauze to each subject's right or left volar forearm will be randomized and double-blinded. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Occurrence, intensity, and relationship of adverse events (AEs) from first dose through the End of Study visit | From first dose through the End of Study visit (Day 14 ± 2 days) |
| Change from Baseline in Clinical Laboratory Tests | Clinical laboratory tests (hematology, chemistry, and urinalysis) | Day 0 (pre-dose), Day 3, and Day 14 ± 2 days |
| Skin Reaction Change from Baseline | skin reaction assessments | Days 0, 1, and 2 (pre- and post-dose), and on Day 3, Day 7 ± 1 day, and Day 14 ± 2 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Livezey, MD | Walter Reed Army Institute of Research (WRAIR) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trials Center, WRAIR | Silver Spring | Maryland | 20910 | United States |
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| AB-SA01 (10^9 PFU per phage) | Biological | Gauze pads will be saturated with AB-SA01 and then applied to each subject's volar forearm and covered with occlusive dressing once daily for 3 consecutive days. Placement of the gauze to each subject's right or left volar forearm will be randomized and double-blinded. |
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| Placebo (for Cohort 10^8) | Biological | Gauze pads will be saturated with Placebo and then applied to each subject's volar forearm and covered with occlusive dressing once daily for 3 consecutive days. Placement of the gauze to each subject's right or left volar forearm will be randomized and double-blinded. |
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| Placebo (for Cohort 10^9) | Biological | Gauze pads will be saturated with Placebo and then applied to each subject's volar forearm and covered with occlusive dressing once daily for 3 consecutive days. Placement of the gauze to each subject's right or left volar forearm will be randomized and double-blinded. |
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