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The purpose of study BMX-02-001 is to evaluate the safety, tolerability and feasibility of orally administered BX002-A to deliver viable bacteriophages to the gut.
Study BMX-02-001 is a randomized, single-blind, placebo-controlled study to evaluate the safety, tolerability, and feasibility of orally administered BX002-A to deliver viable phages that can be measured in the stool.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BX002-A | Experimental | BX002-A: 1 mL liquid for multiple dose oral administration |
|
| Placebo | Placebo Comparator | Placebo: 1 mL liquid for multiple dose oral administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BX002-A | Biological | bacteriophage cocktail |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability: adverse events | Evaluated by reviewing adverse events | Through study completion Day 31 (+ 2 days) |
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| Measure | Description | Time Frame |
|---|---|---|
| Plaque-Forming Unit analysis | Quantitative measurement of viable phage in stool after oral administration of BX002-A via plaque-forming unit analysis | Day -1 through Day 6 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Physician | BiomX, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Facility | Cincinnati | Ohio | 45227 | United States |
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| Other |
Placebo |
|