Clinical study
A Study to Evaluate the Safety, Tolerability, and Fecal Pharmacokinetics of BX002-A in Healthy Adults
| Status | Completed |
|---|---|
| Type | Trial |
| Countries | United States |
| Conditions studied | Healthy Volunteers |
| Study years | 2020–2020 |
| Entry review | 2026-10-03 |
Participation
Check the study record or contact the study team for current recruitment and eligibility.
Study eligibility
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 description
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.
Study registrations
| ClinicalTrials.gov | NCT04737876 |
|---|
Recorded study locations (1)
Locations listed in the study record; this does not confirm current recruitment or treatment outside the study. A site label may be older than the overall study status.
Medical Facility
Cincinnati, Ohio, United States
Recorded site status: Not separately listed. Study location source ↗
Sources and updates
Entry reviewed . This is the date of our source review, not a confirmation of availability today.
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| Study ID | nct04737876 |
|---|