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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04596319
Recruitment Status : Active, not recruiting
First Posted : October 22, 2020
Last Update Posted : December 22, 2022
Sponsor:
Collaborator:
Cystic Fibrosis Foundation
Information provided by (Responsible Party):
Armata Pharmaceuticals, Inc.

Study Description
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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 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 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
Actual Primary Completion Date : December 14, 2022
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arms and Interventions
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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


Outcome Measures
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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 (28 days post last dose of study drug) ]
    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 14 days post last dose of study drug ]
    Change in P. aeruginosa colony-forming units (CFU) per gram of sputum


Eligibility Criteria
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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)
  • 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

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
  • Heavy smoker
Contacts and Locations
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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


Locations
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Sponsors and Collaborators
Armata Pharmaceuticals, Inc.
Cystic Fibrosis Foundation
Investigators
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Study Director: Mina Pastagia, MD, MS Armata Pharmaceuticals, Inc.
More Information
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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: December 22, 2022
Last Verified: December 2022
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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Infections
Communicable Diseases
Pseudomonas Infections
Cystic Fibrosis
Fibrosis
Disease Attributes
Pathologic Processes
Pancreatic Diseases
 Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Gram-Negative Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses