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

NCT04737876 | Completed Phase 1 FDA Drug

• 1 other identifier: BMX-02-001
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability: adverse events

  Evaluated by reviewing adverse events

  Through study completion Day 31 (+ 2 days)

Other Outcomes (1)

• Plaque-Forming Unit analysis

  Day -1 through Day 6

Study Arms (2)

BX002-A

EXPERIMENTAL

BX002-A: 1 mL liquid for multiple dose oral administration

Biological: BX002-A

Placebo

PLACEBO COMPARATOR

Placebo: 1 mL liquid for multiple dose oral administration

Other: Placebo

Interventions

BX002-A BIOLOGICAL

bacteriophage cocktail

BX002-A

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• BiomX, Inc.: lead

Study Sites (1)

Medical Facility

Cincinnati, Ohio, 45227, United States

Location

Study Officials

• Physician

  BiomX, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2021
• First Posted: February 4, 2021
• Study Start: October 28, 2020
• Primary Completion: December 21, 2020
• Study Completion: December 21, 2020
• Last Updated: January 25, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)