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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04737876
• Other study ID #: BMX-02-001
• Status: Completed
• Phase: Phase 1
• Start date: October 28, 2020
• Est. completion date: December 21, 2020

Study information

• Verified date: January 2022
• Source: BiomX, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 21, 2020
• Est. primary completion date: December 21, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Biological:
• BX002-A
bacteriophage cocktail

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
United States	Medical Facility	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
BiomX, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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