Trials / Completed
CompletedNCT04737876
A Study to Evaluate the Safety, Tolerability, and Fecal Pharmacokinetics of BX002-A in Healthy Adults
A Phase 1, Randomized, Single-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Fecal Pharmacokinetics of Orally Administered BX002-A in Healthy Adult Individuals
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 18 (actual)
- Sponsor
- BiomX, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | BX002-A | bacteriophage cocktail |
| OTHER | Placebo | Placebo |
Timeline
- Start date
- 2020-10-28
- Primary completion
- 2020-12-21
- Completion
- 2020-12-21
- First posted
- 2021-02-04
- Last updated
- 2022-01-25
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04737876. Inclusion in this directory is not an endorsement.