A Study to Evaluate the Safety, Tolerability, and Fecal Pharmacokinetics of BX002-A in Healthy Adults

Sponsor

BiomX, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT04737876

Collaborator

(none)

Enrollment

Location

Arms

1.8

Actual Duration (Months)

10.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Biological: BX002-A Other: Placebo	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

18 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Oct 28, 2020

Actual Primary Completion Date :

Dec 21, 2020

Actual Study Completion Date :

Dec 21, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Safety and Tolerability: adverse events [Through study completion Day 31 (+ 2 days)]
Evaluated by reviewing adverse events

Other Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical Facility	Cincinnati	Ohio	United States	45227

Sponsors and Collaborators

BiomX, Inc.

Investigators

Study Director: Physician, BiomX, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

BiomX, Inc.

ClinicalTrials.gov Identifier:

NCT04737876

Other Study ID Numbers:

BMX-02-001

First Posted:

Feb 4, 2021

Last Update Posted:

Jan 25, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jan 25, 2022