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
Purpose
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.
Conditions
- Non-cystic Fibrosis Bronchiectasis
- Pseudomonas Aeruginosa
- Lung Infection
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Double-blind, randomized, placebo-controlled
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental AP-PA02 |
Anti-pseudomonal bacteriophage |
|
|
Placebo Comparator Placebo |
Inactive isotonic solution |
|
Recruiting Locations
Washington, District of Columbia 20007
More Details
- Status
- Recruiting
- Sponsor
- Armata Pharmaceuticals, Inc.
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.