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

Last updated: August 12, 2024
Sponsor: Armata Pharmaceuticals, Inc.
Overall Status: Completed

Phase

2

Condition

Bronchiectasis

Pressure Ulcers

Bronchitis (Pediatric)

Treatment

AP-PA02

Placebo

Clinical Study ID

NCT05616221
AP-PA02-201
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Key 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, andwilling to provide expectorated sputum samples at all other timepoints (for subjectswho 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 regimenfor at least 3 months prior to Visit 1

  • For Cohort B: have received chronic inhaled antipseudomonal antibiotics regimen forat least 3 months prior to Visit 1

Exclusion

Key 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 sourceby vaping

  • Recent changes in either the treatment regimen or initiation of treatment with: oralmacrolides, hypertonic saline, mucolytics, bronchodilator medications, or oralcorticosteroids

  • Currently receiving treatment for active infection at any site

  • Female pregnant of breastfeeding

Study Design

Total Participants: 48
Treatment Group(s): 2
Primary Treatment: AP-PA02
Phase: 2
Study Start date:
January 10, 2023
Estimated Completion Date:
August 08, 2024

Study 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.

Connect with a study center

  • Velocity Clinical Research

    Mobile, Alabama 36608
    United States

    Site Not Available

  • Southern California Institute for Respiratory Diseases Cedars-Sinai West Tower

    Los Angeles, California 90048
    United States

    Site Not Available

  • UCONN Health

    Farmington, Connecticut 06030
    United States

    Site Not Available

  • Georgetown University Hospital / Pulmonary Critical Care and Sleep Medicine

    Washington, District of Columbia 20007
    United States

    Site Not Available

  • Southwest General Healthcare Center

    Fort Myers, Florida 33907
    United States

    Site Not Available

  • TecTum Medical Research, Inc.

    Hollywood, Florida 33024
    United States

    Site Not Available

  • Mayo Clinic/Pulmonary, Critical Care, and Sleep Medicine

    Jacksonville, Florida 32224
    United States

    Site Not Available

  • University of Miami

    Miami, Florida 33146
    United States

    Site Not Available

  • St. Lukes Hospital

    Boise, Idaho 83702
    United States

    Site Not Available

  • The University of Kansas Medical Center / Dept of Medicine

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • Johns Hopkins University School of Medicine

    Baltimore, Maryland 21224
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Rutgers Robert Wood Johnson Medical School

    New Brunswick, New Jersey 08901
    United States

    Site Not Available

  • New York Medical College

    Hawthorne, New York 10595
    United States

    Site Not Available

  • University of Cincinnati - College of Medicine

    Cincinnati, Ohio 45267
    United States

    Site Not Available

  • University Hospitals of Cleveland Medical Center

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Oregon Health & Science University

    Portland, Oregon 97239
    United States

    Site Not Available

  • University of Pennslyvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • University of Texas Health Science Center at Tyler

    Tyler, Texas 75708
    United States

    Site Not Available

  • Virginia Commonwealth University (VCU)

    Richmond, Virginia 23298
    United States

    Site Not Available

  • University of Washington Medical Center

    Seattle, Washington 98195
    United States

    Site Not Available

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