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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase 2, Multi-Center, Double-Blind, Randomized, Placebo Controlled Study to Evaluate the Safety, Phage Kinetics, and Efficacy of Inhaled AP-PA02 Multi-Phage Therapeutic in Subjects With Non-Cystic Fibrosis Bronchiectasis and Chronic Pulmonary Pseudomonas Aeruginosa Infection

Conditions
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Non-cystic Fibrosis Bronchiectasis, Pseudomonas Aeruginosa, Lung Infection

Intervention / Treatment
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* Biological: AP-PA02
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double-blind, randomized, placebo-controlled
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AP-PA02<br>Anti-pseudomonal bacteriophage | Biological: AP-PA02<br>* Bacteriophage administered via inhalation<br>|
| Placebo Comparator: Placebo<br>Inactive isotonic solution | Other: Placebo<br>* Inactive Placebo administered via inhalation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bacteriophage, Phage, NCFB, BE, Pseudomonas, Pseudomonas Aeruginosa