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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04737876

Enrollment

Registered

2021-02-04

Start date

2020-10-28

Completion date

2020-12-21

Last updated

2022-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Brief 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.

Interventions

BIOLOGICALBX002-A

bacteriophage cocktail

OTHERPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

1. Healthy adults 18-65 years old 2. Able to understand study procedures and sign informed consent

Exclusion criteria

1. Evidence or history of clinically significant underlying conditions 2. Women who are pregnant or nursing, or plan to become pregnant during study, or women of childbearing potential not using adequate contraceptive measures 3. History of constipation, severe diarrhea and/or loose stools within 14 days 4. History of procedures aimed at modifying the gastrointestinal microbiota within past year (e.g., fecal microbiota transplantation) 5. Topical gastrointestinal treatment (e.g., enemas) in the 2 weeks prior or planned during study 6. Use of bowel cleansing or preparation in the 4 weeks prior or planned during study 7. Participation in another investigational trial within 30 days 8. Known allergy or hypersensitivity to an excipient in the study drug or placebo 9. Any other reason which according to investigator may impact proper study conduct 10. History of alcohol abuse; drug or medication abuse or tobacco use 11. Subject who cannot be contacted in case of emergency

Design outcomes

Primary

Measure	Time frame	Description
Safety and Tolerability: adverse events	Through study completion Day 31 (+ 2 days)	Evaluated by reviewing adverse events

Other

Measure	Time frame	Description
Plaque-Forming Unit analysis	Day -1 through Day 6	Quantitative measurement of viable phage in stool after oral administration of BX002-A via plaque-forming unit analysis

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026