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

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy Volunteers

In brief

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.

Key facts

Study ID

NCT04737876

Run by

BiomX, Inc.

People needed

18

Starts

2020-10-28

Expected to finish

2020-12-21

Last updated by the study team

2022-01-25

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

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

Where it is running

• Medical Facility — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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