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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Biological: BX002-A; Other: Placebo

• Registration Number: NCT04737876
• Lead Sponsor: BiomX, Inc.

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.

Study Timeline

• Study Start: 2020-10-28
• Primary Completion: 2020-12-21
• Study Completion: 2020-12-21
• Study First Submitted: 2021-01-27
• Study First Submitted QC: 2021-02-03
• Study First Posted: 2021-02-04
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-24
• Last Update Posted: 2022-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BX002-A	BX002-A	BX002-A: 1 mL liquid for multiple dose oral administration
Placebo	Placebo	Placebo: 1 mL liquid for multiple dose oral administration

Primary Outcome Measures

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

Trial Locations

Locations (1)

Medical Facility; 🇺🇸 Cincinnati, Ohio, United States