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Anti-Infective Closed to Enrollment
Study to evaluate nebulized BX004-A in adults with cystic fibrosis and chronic Pseudomonas aeruginosa (BiomX Phase 1b/2a) (BiomX BMX-04-001 Part 2)
This study is testing the safety and tolerability of nebulized BX004-A, a bacteriophage drug intended to treat infections in the lung. Bacteriophages are specialized viruses that kill very specific bacterial strains. Multiple doses of the drug will be tested in adults with cystic fibrosis and chronic Pseudomonas aeruginosa (PsA) to find the best dose.
This study will take place in two parts that are both randomized and placebo-controlled. This means that some participants will be randomly assigned to receive the study drug, and some participants will be randomly assigned to receive placebo. In Part 1, participants will be given single doses at different dose levels and multiple doses of BX004-A or placebo. In Part 2, participants will be given multiple doses of BX004-A or placebo. Participants in both parts will be included in a 6-month safety follow-up. Researchers will measure the safety and tolerability of the drug. They will also measure PsA levels in sputum to see if the drug reduces bacterial load.This study may require sputum or throat swab collection, and/or additional procedures.
Eligibility
See other primary eligibility criteria for more information.
-
Age:
18 Years and Older -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
40% or greater
For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.
Other Primary Eligibility Criteria
Chronic pulmonary PsA infection defined as: Baseline culture and one additional culture with PsA isolated within the 6-12 months prior to Screening; Currently receiving inhaled aztreonam or tobramycin.
Study Design
-
Study Type: ?more info
Interventional -
Randomized Study: ?more info
Yes -
Placebo Controlled: ?more info
Yes -
Length of Participation:
192 days -
Number of Study Visits:
7
Additional Information
-
Phase: ?more info
Phase Two -
Study Sponsor: ?more info
BiomX -
Study Drugs:
Study Sites
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Closed to Enrollment
Alabama
University of Alabama at Birmingham, Birmingham, AL 35233
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Closed to Enrollment
Alaska
Providence Alaska Medical Center, Anchorage, AK 99508
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Closed to Enrollment
Arkansas
University of Arkansas for Medical Sciences, Little Rock, AR 72205
-
Closed to Enrollment
Connecticut
Yale University School of Medicine, New Haven, CT 06520
-
Closed to Enrollment
District of Columbia
MedStar Washington Hospital Center, Washington, DC 20010
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Closed to Enrollment
Florida
Central Florida Pulmonary Group, Orlando, FL 32803
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Closed to Enrollment
Florida
University of Florida, Gainesville, FL 32610
-
Closed to Enrollment
Florida
Joe DiMaggio Children's Hospital, Hollywood, FL 33021
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Closed to Enrollment
Massachusetts
Boston Children's Hospital, Brigham & Women's Hospital, Boston, MA 02115
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Closed to Enrollment
New York
New York Medical College at Westchester Medical Center, Valhalla, NY 10595
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Closed to Enrollment
Ohio
Cincinnati Children's Hospital Medical Center, Cincinnati, OH 45229
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Closed to Enrollment
Ohio
Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center, Cleveland, OH 44106
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Closed to Enrollment
Ohio
Nationwide Children's Hospital, Columbus, OH 43205
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Closed to Enrollment
Pennsylvania
Hershey Medical Center Pennsylvania State University, Hershey, PA 17033
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Closed to Enrollment
South Carolina
Medical University of South Carolina, Charleston, SC 29425
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Closed to Enrollment
Texas
Baylor College of Medicine, Houston, TX 77030
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Closed to Enrollment
Utah
Adult Cystic Fibrosis Center at the University of Utah, Salt Lake City, UT 84112
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Closed to Enrollment
Washington
Seattle Children's Hospital, Seattle, WA 98105
Eligibility
See other primary eligibility criteria for more information.
-
Age:
18 Years and Older -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
40% or greater -
Pseudomonas Status:
Positive Respiratory Cultures Required
For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.
Other Primary Eligibility Criteria
Chronic pulmonary PsA infection defined as: Baseline culture and one additional culture with PsA isolated within the 6-12 months prior to Screening; Currently receiving inhaled aztreonam or tobramycin.

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