Overview
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.
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.
Eligibility
Key Inclusion Criteria:
- ≥ 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 Exclusion Criteria:
- 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