A phase 2, multi-center, double-blind, randomized, placebo-controlled study to evaluate the safety, phage kinetics, and efficacy of inhaled AP-PA02 administered in subjects with non-cystic fibrosis bronchiectasis and chronic pulmonary Pseudomonas aeruginosa infection.
This study will be conducted in two cohorts running in parallel: Cohort A will evaluate the safety, tolerability, and efficacy of inhaled AP-PA02 in subjects who have not received an antipseudomonal inhaled antibiotic for a minimum of 3 months prior. Cohort B will evaluate the safety, tolerability, and efficacy of inhaled AP-PA02 in subjects who have received an antipseudomonal inhaled antibiotic for a minimum of 3 months prior. Subjects in both Cohorts A and B will be followed for approximately 4 weeks after last dose of study drug and evaluated for safety, tolerability, and efficacy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
48
Velocity Clinical Research
Mobile, Alabama, United States
Southern California Institute for Respiratory Diseases Cedars-Sinai West Tower
Los Angeles, California, United States
UCONN Health
Farmington, Connecticut, United States
Georgetown University Hospital / Pulmonary Critical Care and Sleep Medicine
Washington D.C., District of Columbia, United States
Southwest General Healthcare Center
Fort Myers, Florida, United States
TecTum Medical Research, Inc.
Hollywood, Florida, United States
Mayo Clinic/Pulmonary, Critical Care, and Sleep Medicine
Jacksonville, Florida, United States
University of Miami
Miami, Florida, United States
St. Lukes Hospital
Boise, Idaho, United States
The University of Kansas Medical Center / Dept of Medicine
Kansas City, Kansas, United States
...and 13 more locations
P. Aeruginosa Recovery in Sputum Following Multiple Doses of AP-PA02 Administered by Inhalation
Change from baseline in P. Aeruginosa density (colony forming units) as measured in induced sputum samples one week after end of treatment.
Time frame: Day 17
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