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

Phase 2

Completed

• Conditions: Lung Infection; Non-cystic Fibrosis Bronchiectasis; Pseudomonas Aeruginosa
• Interventions: Other: Placebo; Biological: AP-PA02

• Registration Number: NCT05616221
• Lead Sponsor: Armata Pharmaceuticals, Inc.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations
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Related News

Study Timeline

• Study First Submitted: 2022-11-07
• Study First Submitted QC: 2022-11-07
• Study First Posted: 2022-11-15
• Study Start: 2023-01-10
• Primary Completion: 2024-07-17
• Status Verified: 2024-08
• Study Completion: 2024-08-08
• Last Update Submitted: 2024-08-12
• Last Update Posted: 2024-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Inactive isotonic solution
AP-PA02	AP-PA02	Anti-pseudomonal bacteriophage

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (23)

Johns Hopkins University School of Medicine; 🇺🇸 Baltimore, Maryland, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

University of Pennslyvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Virginia Commonwealth University (VCU); 🇺🇸 Richmond, Virginia, United States

University of Washington Medical Center; 🇺🇸 Seattle, Washington, United States

University of Texas Health Science Center at Tyler; 🇺🇸 Tyler, Texas, United States

Velocity Clinical Research; 🇺🇸 Mobile, Alabama, United States

TecTum Medical Research, Inc.; 🇺🇸 Hollywood, Florida, United States

University Hospitals of Cleveland Medical Center; 🇺🇸 Cleveland, Ohio, United States

New York Medical College; 🇺🇸 Hawthorne, New York, United States

University of Cincinnati - College of Medicine; 🇺🇸 Cincinnati, Ohio, United States

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States

The University of Kansas Medical Center / Dept of Medicine; 🇺🇸 Kansas City, Kansas, United States

Mayo Clinic/Pulmonary, Critical Care, and Sleep Medicine; 🇺🇸 Jacksonville, Florida, United States

Southern California Institute for Respiratory Diseases Cedars-Sinai West Tower; 🇺🇸 Los Angeles, California, United States

Southwest General Healthcare Center; 🇺🇸 Fort Myers, Florida, United States

St. Lukes Hospital; 🇺🇸 Boise, Idaho, United States

UCONN Health; 🇺🇸 Farmington, Connecticut, United States

Rutgers Robert Wood Johnson Medical School; 🇺🇸 New Brunswick, New Jersey, United States

University of Miami; 🇺🇸 Miami, Florida, United States

Georgetown University Hospital / Pulmonary Critical Care and Sleep Medicine; 🇺🇸 Washington, District of Columbia, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States