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

ArmDescriptionAssigned Intervention
Experimental
AP-PA02 		Anti-pseudomonal bacteriophage
  • Biological: AP-PA02
    Bacteriophage administered via inhalation
Placebo Comparator
Placebo 		Inactive isotonic solution
  • Other: Placebo
    Inactive Placebo administered via inhalation

Recruiting Locations

Georgetown University Hospital / Pulmonary Critical Care and Sleep Medicine
Washington, District of Columbia 20007
Contact:
Amen Hamed
202-444-8830
Amen.M.Hamed@gunet.georgetown.edu

More Details

Status
Recruiting
Sponsor
Armata Pharmaceuticals, Inc.

Study Contact

Pierre Kyme, PhD
310-665-2928
pkyme@armatapharma.com

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.