Study to Evaluate the Safety, Phage Kinetics, and Efficacy of Inhaled AP-PA02 in Subjects With Non-Cystic Fibrosis Bronchiectasis and Chronic Pulmonary Pseudomonas Aeruginosa Infection
- Conditions
- Lung InfectionNon-cystic Fibrosis BronchiectasisPseudomonas Aeruginosa
- Interventions
- Other: PlaceboBiological: AP-PA02
- Registration Number
- NCT05616221
- Lead Sponsor
- Armata Pharmaceuticals, Inc.
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
- ≥ 18 years old
- Body mass index (BMI) of ≥ 18 kg/m2
- Evidence of bronchiectasis per CT
- Evidence of chronic pulmonary Pseudomonas aeruginosa infection
- Willing to undergo sputum induction procedures at designated study visits, and willing to provide expectorated sputum samples at all other timepoints (for subjects who are able to expectorate)
- FEV1 ≥ 35% of predicted normal [per Global Lung Function Initiative (GLI) standards] at Screening
- For Cohort A: have not received chronic inhaled antipseudomonal antibiotics regimen for at least 3 months prior to Visit 1
- For Cohort B: have received chronic inhaled antipseudomonal antibiotics regimen for at least 3 months prior to Visit 1
Key
- Abnormal vital signs at Screening
- History of lung transplantation
- History of cystic fibrosis
- History of α1-antitrypsin deficiency
- History of primary or acquired immunodeficiency syndromes
- History of COPD
- History of pulmonary malignancy or any other malignancy requiring treatment
- History of prolonged QT syndrome
- History of hemoptysis
- Recent significant weight loss
- Recent use of supplemental oxygen during the day while at rest
- Recent use of cigarettes, cigars, or pipes, or used tobacco or other nicotine source by vaping
- Recent changes in either the treatment regimen or initiation of treatment with: oral macrolides, hypertonic saline, mucolytics, bronchodilator medications, or oral corticosteroids
- Currently receiving treatment for active infection at any site
- Female pregnant of breastfeeding
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Inactive isotonic solution AP-PA02 AP-PA02 Anti-pseudomonal bacteriophage
- Primary Outcome Measures
Name Time Method P. aeruginosa recovery in sputum following multiple doses of AP-PA02 administered by inhalation Day 1 pre-dose through 7 days post last dose of study drug
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (23)
Johns Hopkins University School of Medicine
🇺🇸Baltimore, Maryland, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
University of Pennslyvania
🇺🇸Philadelphia, Pennsylvania, United States
Virginia Commonwealth University (VCU)
🇺🇸Richmond, Virginia, United States
University of Washington Medical Center
🇺🇸Seattle, Washington, United States
University of Texas Health Science Center at Tyler
🇺🇸Tyler, Texas, United States
Velocity Clinical Research
🇺🇸Mobile, Alabama, United States
TecTum Medical Research, Inc.
🇺🇸Hollywood, Florida, United States
University Hospitals of Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
New York Medical College
🇺🇸Hawthorne, New York, United States
University of Cincinnati - College of Medicine
🇺🇸Cincinnati, Ohio, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
The University of Kansas Medical Center / Dept of Medicine
🇺🇸Kansas City, Kansas, United States
Mayo Clinic/Pulmonary, Critical Care, and Sleep Medicine
🇺🇸Jacksonville, Florida, United States
Southern California Institute for Respiratory Diseases Cedars-Sinai West Tower
🇺🇸Los Angeles, California, United States
Southwest General Healthcare Center
🇺🇸Fort Myers, Florida, United States
St. Lukes Hospital
🇺🇸Boise, Idaho, United States
UCONN Health
🇺🇸Farmington, Connecticut, United States
Rutgers Robert Wood Johnson Medical School
🇺🇸New Brunswick, New Jersey, United States
University of Miami
🇺🇸Miami, Florida, United States
Georgetown University Hospital / Pulmonary Critical Care and Sleep Medicine
🇺🇸Washington, District of Columbia, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States