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Ph 1/2 Study Evaluating Safety and Tolerability of Inhaled AP-PA02 in Subjects With Chronic Pseudomonas Aeruginosa Lung Infections and Cystic Fibrosis (SWARM-Pa)

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ClinicalTrials.gov Identifier: NCT04596319
Recruitment Status : Recruiting
First Posted : October 22, 2020
Last Update Posted : March 25, 2021
Sponsor:
Collaborator:
Cystic Fibrosis Foundation
Information provided by (Responsible Party):
Armata Pharmaceuticals, Inc.

Brief Summary:
Phase 1b/2a, double-blind, randomized, placebo-controlled, single and multiple ascending dose study to evaluate the safety, tolerability and phage recovery profile of AP-PA02 multi-bacteriophage therapeutic candidate administered by inhalation in subjects with cystic fibrosis and chronic pulmonary Pseudomonas aeruginosa (PA) infection.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Pseudomonas Aeruginosa Pseudomonas Lung Infection Lung Infection Pseudomonal Biological: AP-PA02 Other: Placebo Phase 1 Phase 2

Detailed Description:

The study consists of two parts. Subjects with Cystic Fibrosis and chronic pulmonary Pseudomonas aeruginosa (PA) infection will be enrolled in either Part 1 (single-ascending dose cohorts) or Part 2 (multiple-ascending dose cohorts).

Part 1 will evaluate single doses of AP-PA02 at three ascending dose levels, administered by inhalation. Treatment assignment will be randomized, double-blind, placebo-controlled in each of three 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 three 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, double-blind, placebo-controlled
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 1b/2a, Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety and Tolerability of AP-PA02 Multi-Phage Therapeutic Candidate for Inhalation in Subjects With Cystic Fibrosis and Chronic Pulmonary Pseudomonas Aeruginosa (Pa) Infection
Actual Study Start Date : December 22, 2020
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Incidence of Treatment Emergent Adverse Events (Safety and Tolerability) of single and multiple doses of AP-PA02 administered by inhalation [ Time Frame: Day 1 pre-dose through End of Study Visit (Day 29 for SAD, Day 31 for MAD) ]
    Incidence and severity of treatment-emergent adverse events


Secondary Outcome Measures :
  1. Part 2 (MAD) Only: Explore P. aeruginosa recovery in sputum following multiple doses of AP-PA02 administered by inhalation [ Time Frame: Baseline (Day -1) through Visit 7 (Day 17) ]
    Change in P. aeruginosa colony-forming units (CFU) per gram of sputum



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • ≥ 18 years old
  • 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)
  • FEV1 ≥ 60% of predicted normal [per Global Lung Function Initiative (GLI) standards] at Screening
  • Adequate renal function

Key Exclusion Criteria:

  • Recent significant weight loss
  • 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
  • Use of tobacco in any form, or use of e-cigarettes/vaping within 6 months prior to Screening

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04596319


Contacts
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Contact: Vicki White, BS 310-633-4566 vwhite@armatapharma.com
Contact: Pierre Kyme, PhD 310-665-2928 ext 234 pkyme@armatapharma.com

Locations
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United States, California
Children's Hospital Los Angeles Recruiting
Los Angeles, California, United States, 90027
Contact: Carmen Reyes       mareyes@chla.usc.edu   
Principal Investigator: Thomas Keens, MD         
United States, Florida
University of South Florida Recruiting
Tampa, Florida, United States, 33606
Contact: Kristin Grube    813-844-8624    klgrube@usf.edu   
Principal Investigator: Timothy Floreth, MD         
United States, Idaho
St. Luke's Cystic Fibrosis Center of Idaho Recruiting
Boise, Idaho, United States, 83712
Contact: Lejla Godusevic    208-381-4717    godusevl@slhs.org   
Principal Investigator: Perry Brown, MD, FAAP         
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60208
Contact: Rachel Nelson       rachel.nelson@northwestern.edu   
Principal Investigator: Manu Jain, MD         
United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Mary Teresi       mary-teresi@uiowa.edu   
Principal Investigator: Tahuanty Pena, MD         
United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Robert Fowler       Robert.Fowler@childrens.harvard.edu   
Principal Investigator: Henry Dorkin, MD         
United States, Ohio
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Contact: Terri Johnson       Terri.Johnson@nationwidechildrens.org   
Principal Investigator: Karen McCoy, MD         
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Max Lento       lento@musc.edu   
Principal Investigator: Patrick Flume, MD         
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Brijesh Patel       Brijesh.Patel@vumc.org   
Contact: James J Tolle, MD       James.J.Tolle@vanderbilt.edu   
Principal Investigator: James J Tolle, MD         
United States, Texas
University of Texas Southwestern Recruiting
Dallas, Texas, United States, 75390
Contact: Ashley Keller       ashley.keller@utsouhtwestern.edu   
Contact: Raksha Jain, MD       Raksha.Jain@UTSouthwestern.edu   
Principal Investigator: Raksha Jain, MD         
Sponsors and Collaborators
Armata Pharmaceuticals, Inc.
Cystic Fibrosis Foundation
Investigators
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Study Director: Mina Pastagia, MD, MS Armata Pharmaceuticals, Inc.
Additional Information:
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Responsible Party: Armata Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT04596319    
Other Study ID Numbers: AP-PA02-101
First Posted: October 22, 2020    Key Record Dates
Last Update Posted: March 25, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Armata Pharmaceuticals, Inc.:
phage
bacteriophage
cystic fibrosis
Pseudomonas
Pseudomonas aeruginosa
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Pseudomonas Infections
Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Gram-Negative Bacterial Infections
Bacterial Infections