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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04596319
Recruitment Status : Recruiting
First Posted : October 22, 2020
Last Update Posted : November 23, 2020
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
Estimated Study Start Date : December 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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)
  • 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, 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, Texas
University of Texas Southwestern Not yet recruiting
Dallas, Texas, United States, 75390
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: November 23, 2020
Last Verified: November 2020
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