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

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.

Inclusion criteria

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

Exclusion criteria

• 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