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

BiomX

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Other: Placebo; Biological: BX002-A

Study type: Interventional

Funder types: Industry

Identifiers

NCT04737876

BMX-02-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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18 participants in 2 patient groups, including a placebo group

BX002-A

Experimental group

Description:

BX002-A: 1 mL liquid for multiple dose oral administration

Treatment:

Biological: BX002-A

Placebo

Placebo Comparator group

Description:

Placebo: 1 mL liquid for multiple dose oral administration

Treatment:

Other: Placebo