Status:
COMPLETED
A Study to Evaluate the Safety, Tolerability, and Fecal Pharmacokinetics of BX002-A in Healthy Adults
Lead Sponsor:
BiomX, Inc.
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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 measu...
Eligibility Criteria
Inclusion
- Healthy adults 18-65 years old
- Able to understand study procedures and sign informed consent
Exclusion
- 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
Key Trial Info
Start Date :
October 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 21 2020
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04737876
Start Date
October 28 2020
End Date
December 21 2020
Last Update
January 25 2022
Active Locations (1)
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1
Medical Facility
Cincinnati, Ohio, United States, 45227