Ph 1/2 Study Evaluating Safety and Tolerability of Inhaled AP-PA02 in Subjects With Chronic Pseudomonas Aeruginosa Lung Infections and Cystic Fibrosis
NCT ID: NCT04596319
Last Updated: 2024-01-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
29 participants
INTERVENTIONAL
2020-12-22
2022-12-14
Brief Summary
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Detailed Description
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Part 1 will evaluate single doses of AP-PA02 at two ascending dose levels, administered by inhalation. Treatment assignment will be randomized, double-blind, placebo-controlled in each of two ascending dose cohorts. Part 2 will also be double-blinded, randomized, placebo controlled, and will evaluate the safety and efficacy of multiple doses of AP-PA02 in each of two ascending dose level cohorts.
Subjects in both Parts 1 and 2 will be followed for approximately 4 weeks and evaluated for safety, tolerability, phage titer profile and immunogenicity.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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AP-PA02
Anti-pseudomonal bacteriophage
AP-PA02
Bacteriophage administered via inhalation
Placebo
Inactive isotonic solution
Placebo
Inactive Placebo administered via inhalation
Interventions
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AP-PA02
Bacteriophage administered via inhalation
Placebo
Inactive Placebo administered via inhalation
Eligibility Criteria
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Inclusion Criteria
* Body mass index (BMI) of ≥ 18 kg/m2
* Documented diagnosis of CF
* 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)
* For SAD: FEV1 ≥ 60% of predicted normal \[per Global Lung Function Initiative (GLI) standards\] at Screening
* For MAD: FEV1 ≥ 40% of predicted normal \[per Global Lung Function Initiative (GLI) standards\] at Screening
* Adequate renal function
Exclusion Criteria
* Abnormal vital signs at Screening
* History of prolonged QT syndrome
* Use of supplemental oxygen during the day at rest
* Abnormal liver function tests greater than 3X the upper limit of normal (ULN)
* Recent oral or IV antibiotics received for acute pulmonary exacerbation. Inhaled antibiotic use for chronic suppression of P. aeruginosa is acceptable.
* Recent clinically significant infection requiring systemic antimicrobial therapy
* Currently receiving anti-pseudomonal antibiotic treatment for acute sinusitis.
* Currently receiving systemic corticosteroids
* Currently receiving treatment for active infection with nontuberculous mycobacteria (NTM), Staphylococcus aureus, or Burkholderia cepacia complex lung infection
* Currently receiving treatment for aspergillosis or ABPA (allergic bronchopulmonary aspergillosis)
* Initiation of a CFTR potentiator/corrector therapy, such as Trikafta®, less than 90 days prior to Screening
* Acquired or primary immunodeficiency syndromes
* Active pulmonary malignancy (primary or metastatic)
* History of lung transplantation
* Recent hemoptysis
* Female pregnant or breastfeeding
* Heavy smoker
18 Years
ALL
No
Sponsors
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Cystic Fibrosis Foundation
OTHER
Armata Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Mina Pastagia, MD, MS
Role: STUDY_DIRECTOR
Armata Pharmaceuticals, Inc.
Locations
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Children's Hospital Los Angeles
Los Angeles, California, United States
University of South Florida
Tampa, Florida, United States
St. Luke's Cystic Fibrosis Center of Idaho
Boise, Idaho, United States
Northwestern University
Chicago, Illinois, United States
University of Iowa
Iowa City, Iowa, United States
The University of Kansas Medical Center
Kansas City, Kansas, United States
Johns Hopkins University
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Harper University Hospital
Detroit, Michigan, United States
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
New York Medical College
Valhalla, New York, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
The Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
University of Texas Southwestern
Dallas, Texas, United States
University of Washington
Seattle, Washington, United States
University of Wisconsin
Madison, Wisconsin, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Armata Pharmaceuticals, Inc.
Other Identifiers
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AP-PA02-101
Identifier Type: -
Identifier Source: org_study_id
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