Clinical Trial Finder

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

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.

Arms

Experimental: AP-PA02

Anti-pseudomonal bacteriophage

Placebo Comparator: Placebo

Inactive isotonic solution

Interventions

Biological: - AP-PA02

Bacteriophage administered via inhalation

Other: - Placebo

Inactive Placebo administered via inhalation