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

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 Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Other: Placebo; Biological: BX002-A

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45227
      • Medical facility

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: BX002-A; BX002-A: 1 mL liquid for multiple dose oral administration	Biological: BX002-A; bacteriophage cocktail
PLACEBO_COMPARATOR: Placebo; Placebo: 1 mL liquid for multiple dose oral administration	Other: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

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

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: BiomX, Inc.
• Investigators: Study Director: Physician, BiomX, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 28, 2020
• Primary Completion (ACTUAL): December 21, 2020
• Study Completion (ACTUAL): December 21, 2020

Study Registration Dates

• First Submitted: January 27, 2021
• First Submitted That Met QC Criteria: February 3, 2021
• First Posted (ACTUAL): February 4, 2021

Study Record Updates

• Last Update Posted (ACTUAL): January 25, 2022
• Last Update Submitted That Met QC Criteria: January 24, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: BMX-02-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No