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

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.

Key Inclusion Criteria:≥ 18 years oldBody mass index (BMI) of ≥ 18 kg/m2Evidence of bronchiectasis per CTEvidence of chronic pulmonary Pseudomonas aeruginosa infectionWilling 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 ScreeningFor Cohort A: have not received chronic inhaled antipseudomonal antibiotics regimen for at least 3 months prior to Visit 1For Cohort B: have received chronic inhaled antipseudomonal antibiotics regimen for at least 3 months prior to Visit 1Key Exclusion Criteria:Abnormal vital signs at ScreeningHistory of lung transplantationHistory of cystic fibrosisHistory of α1-antitrypsin deficiencyHistory of primary or acquired immunodeficiency syndromesHistory of COPDHistory of pulmonary malignancy or any other malignancy requiring treatmentHistory of prolonged QT syndromeHistory of hemoptysisRecent significant weight lossRecent use of supplemental oxygen during the day while at restRecent use of cigarettes, cigars, or pipes, or used tobacco or other nicotine source by vapingRecent changes in either the treatment regimen or initiation of treatment with: oral macrolides, hypertonic saline, mucolytics, bronchodilator medications, or oral corticosteroidsCurrently receiving treatment for active infection at any siteFemale pregnant of breastfeeding