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

NCT05616221 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: AP-PA02-201
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 23

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.

Conditions

Lung Infection; Non-cystic Fibrosis Bronchiectasis; Pseudomonas Aeruginosa

Keywords

Bacteriophage; Phage; NCFB; BE; Pseudomonas; Pseudomonas Aeruginosa

Outcome Measures

Primary Outcomes (1)

• P. Aeruginosa Recovery in Sputum Following Multiple Doses of AP-PA02 Administered by Inhalation

  Change from baseline in P. Aeruginosa density (colony forming units) as measured in induced sputum samples one week after end of treatment.

  Day 17

Study Arms (2)

AP-PA02

EXPERIMENTAL

Anti-pseudomonal bacteriophage

Biological: AP-PA02

Placebo

PLACEBO COMPARATOR

Inactive isotonic solution

Other: Placebo

Interventions

AP-PA02 BIOLOGICAL

Bacteriophage administered via inhalation

AP-PA02

Placebo OTHER

Inactive Placebo administered via inhalation

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Armata Pharmaceuticals, Inc.: lead

Study Sites (23)

Velocity Clinical Research

Mobile, Alabama, 36608, United States

Location

Southern California Institute for Respiratory Diseases Cedars-Sinai West Tower

Los Angeles, California, 90048, United States

Location

UCONN Health

Farmington, Connecticut, 06030, United States

Location

Georgetown University Hospital / Pulmonary Critical Care and Sleep Medicine

Washington D.C., District of Columbia, 20007, United States

Location

Southwest General Healthcare Center

Fort Myers, Florida, 33907, United States

Location

TecTum Medical Research, Inc.

Hollywood, Florida, 33024, United States

Location

Mayo Clinic/Pulmonary, Critical Care, and Sleep Medicine

Jacksonville, Florida, 32224, United States

Location

University of Miami

Miami, Florida, 33146, United States

Location

St. Lukes Hospital

Boise, Idaho, 83702, United States

Location

The University of Kansas Medical Center / Dept of Medicine

Kansas City, Kansas, 66160, United States

Location

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21224, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Rutgers Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08901, United States

Location

New York Medical College

Hawthorne, New York, 10595, United States

Location

University of Cincinnati - College of Medicine

Cincinnati, Ohio, 45267, United States

Location

University Hospitals of Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

University of Pennslyvania

Philadelphia, Pennsylvania, 19104, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37203, United States

Location

University of Texas Health Science Center at Tyler

Tyler, Texas, 75708, United States

Location

Virginia Commonwealth University (VCU)

Richmond, Virginia, 23298, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

Related Links

• Armata Pharmaceuticals, Inc.

MeSH Terms

Conditions

Pseudomonas Infections

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: Jennifer Smith
• Organization: Armata Pharmaceuticals, Inc.

jsmith@armatapharma.com

310-665-2928

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double-blind, randomized, placebo-controlled

Study Record Dates

• First Submitted: November 7, 2022
• First Posted: November 15, 2022
• Study Start: January 10, 2023
• Primary Completion: July 17, 2024
• Study Completion: August 8, 2024
• Last Updated: January 5, 2026
• Results First Posted: January 5, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (23)