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
Overview
- Phase
- Phase 2
- Intervention
- AP-PA02
- Conditions
- Non-cystic Fibrosis Bronchiectasis
- Sponsor
- Armata Pharmaceuticals, Inc.
- Enrollment
- 48
- Locations
- 29
- Primary Endpoint
- P. Aeruginosa Recovery in Sputum Following Multiple Doses of AP-PA02 Administered by Inhalation
- Status
- Completed
- Last Updated
- 3 months ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
AP-PA02
Anti-pseudomonal bacteriophage
Intervention: AP-PA02
Placebo
Inactive isotonic solution
Intervention: Placebo
Outcomes
Primary Outcomes
P. Aeruginosa Recovery in Sputum Following Multiple Doses of AP-PA02 Administered by Inhalation
Time Frame: Day 17
Change from baseline in P. Aeruginosa density (colony forming units) as measured in induced sputum samples one week after end of treatment.