Page Title
Clinical Trial Finder
Anti-Infective Closed to Enrollment
Study to evaluate inhaled AP-PA02 in adults with cystic fibrosis and chronic Pseudomonas aeruginosa (Armata Phase 1b/2 SAD) (Armata AP-PA02-101 - SAD)
This study will look at the safety and tolerability of inhaled AP-PA02, 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 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 receive the study drug and some participants will receive a placebo. In Part 1 of this study, researchers will measure the safety and tolerability of single doses of inhaled AP-PA02 at three increasing levels. They will do this by monitoring for adverse events.This study will require physical exams, lung function tests, sputum induction, expectorated sputum collection, and/or other additional procedures.
Eligibility
See other primary eligibility criteria for more information.
-
Age:
18 Years and Older -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
60% or greater
For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.
Other Primary Eligibility Criteria
Study Design
-
Study Type: ?more info
Interventional -
Randomized Study: ?more info
Yes -
Placebo Controlled: ?more info
Yes -
Length of Participation:
29 days -
Number of Study Visits:
8
Additional Information
-
Phase: ?more info
Phase One -
Study Sponsor: ?more info
Armata -
Study Drugs:
Study Sites
-
Closed to Enrollment
California
Children's Hospital of Los Angeles, Los Angeles, CA 90027
-
Closed to Enrollment
Florida
Tampa General Hospital, Tampa, FL 33606
-
Closed to Enrollment
Florida
University of Miami, Miami, FL 33136
-
Closed to Enrollment
Idaho
Saint Luke's Cystic Fibrosis Center of Idaho, Boise, ID 83702
-
Closed to Enrollment
Illinois
Northwestern University, Chicago, IL 60611
-
Closed to Enrollment
Iowa
University of Iowa, Iowa City, IA 52242
-
Closed to Enrollment
Maryland
Johns Hopkins University, Baltimore, MD 21205
-
Closed to Enrollment
Massachusetts
Massachusetts General Hospital, Boston, MA 02114
-
Closed to Enrollment
Massachusetts
Boston Children's Hospital, Boston, MA 02115
-
Closed to Enrollment
New Jersey
Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ 08901
-
Closed to Enrollment
Ohio
University of Cincinnati Medical Center, Cincinnati, OH 45267
-
Closed to Enrollment
Ohio
Cleveland Clinic Cystic Fibrosis Program, Cleveland, OH 44195
-
Closed to Enrollment
Ohio
Nationwide Children's Hospital, Columbus, OH 43205
-
Closed to Enrollment
Pennsylvania
University of Pennsylvania, Philadelphia, PA 19104
-
Closed to Enrollment
South Carolina
Medical University of South Carolina, Charleston, SC 29425
-
Closed to Enrollment
Tennessee
Vanderbilt University Medical Center, Nashville, TN 37232
-
Closed to Enrollment
Texas
University of Texas Southwestern, Dallas, TX 75390
-
Closed to Enrollment
Washington
University of Washington Medical Center, Seattle, WA 98195
-
Closed to Enrollment
Wisconsin
University of Wisconsin, Madison, WI 53792
Eligibility
See other primary eligibility criteria for more information.
-
Age:
18 Years and Older -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
60% 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
Sign up for clinical trial alerts
Get email updates about clinical trials that matter to you.
Check the Drug Development Pipeline
We’re attacking CF from every angle. Learn about the status of CF drugs in development.
Learn More