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Trial record 1 of 1 for:    bx002
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A Study to Evaluate the Safety, Tolerability, and Fecal Pharmacokinetics of BX002-A in Healthy Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04737876
Recruitment Status : Completed
First Posted : February 4, 2021
Last Update Posted : January 25, 2022
Sponsor:
Information provided by (Responsible Party):
BiomX, Inc.

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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Biological: BX002-A Other: Placebo Phase 1

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 measured in the stool.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: A Phase 1, Randomized, Single-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Fecal Pharmacokinetics of Orally Administered BX002-A in Healthy Adult Individuals
Actual Study Start Date : October 28, 2020
Actual Primary Completion Date : December 21, 2020
Actual Study Completion Date : December 21, 2020

Arm Intervention/treatment
Experimental: BX002-A
BX002-A: 1 mL liquid for multiple dose oral administration
Biological: BX002-A
bacteriophage cocktail

Placebo Comparator: Placebo
Placebo: 1 mL liquid for multiple dose oral administration
Other: Placebo
Placebo




Primary Outcome Measures :
  1. Safety and Tolerability: adverse events [ Time Frame: Through study completion Day 31 (+ 2 days) ]
    Evaluated by reviewing adverse events


Other Outcome Measures:
  1. Plaque-Forming Unit analysis [ Time Frame: Day -1 through Day 6 ]
    Quantitative measurement of viable phage in stool after oral administration of BX002-A via plaque-forming unit analysis



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04737876


Locations
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United States, Ohio
Medical Facility
Cincinnati, Ohio, United States, 45227
Sponsors and Collaborators
BiomX, Inc.
Investigators
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Study Director: Physician BiomX, Inc.
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Responsible Party: BiomX, Inc.
ClinicalTrials.gov Identifier: NCT04737876    
Other Study ID Numbers: BMX-02-001
First Posted: February 4, 2021    Key Record Dates
Last Update Posted: January 25, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No