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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)

Primary Purpose

Cystic Fibrosis, Pseudomonas Aeruginosa, Pseudomonas

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
AP-PA02
Placebo
Sponsored by
Armata Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystic Fibrosis focused on measuring phage, bacteriophage, cystic fibrosis, Pseudomonas, Pseudomonas aeruginosa

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Hospital Los Angeles
  • University of South Florida
  • St. Luke's Cystic Fibrosis Center of Idaho
  • Northwestern University
  • University of Iowa
  • The University of Kansas Medical Center
  • Johns Hopkins University
  • Massachusetts General Hospital
  • Boston Children's Hospital
  • Harper University Hospital
  • Rutgers Robert Wood Johnson Medical School
  • New York Medical College
  • University Hospitals Cleveland Medical Center
  • Nationwide Children's Hospital
  • The Hospital of the University of Pennsylvania
  • Medical University of South Carolina
  • Vanderbilt University Medical Center
  • University of Texas Southwestern
  • University of Washington
  • University of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

AP-PA02

Placebo

Arm Description

Anti-pseudomonal bacteriophage

Inactive isotonic solution

Outcomes

Primary Outcome Measures

Incidence of Treatment Emergent Adverse Events (Safety and Tolerability) of single and multiple doses of AP-PA02 administered by inhalation
Incidence and severity of treatment-emergent adverse events

Secondary Outcome Measures

Part 2 (MAD) Only: Explore P. aeruginosa recovery in sputum following multiple doses of AP-PA02 administered by inhalation
Change in P. aeruginosa colony-forming units (CFU) per gram of sputum

Full Information

First Posted
October 15, 2020
Last Updated
August 18, 2023
Sponsor
Armata Pharmaceuticals, Inc.
Collaborators
Cystic Fibrosis Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04596319
Brief Title
Ph 1/2 Study Evaluating Safety and Tolerability of Inhaled AP-PA02 in Subjects With Chronic Pseudomonas Aeruginosa Lung Infections and Cystic Fibrosis
Acronym
SWARM-Pa
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
December 22, 2020 (Actual)
Primary Completion Date
December 14, 2022 (Actual)
Study Completion Date
December 14, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Armata Pharmaceuticals, Inc.
Collaborators
Cystic Fibrosis Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis, Pseudomonas Aeruginosa, Pseudomonas, Lung Infection, Lung Infection Pseudomonal
Keywords
phage, bacteriophage, cystic fibrosis, Pseudomonas, Pseudomonas aeruginosa

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Randomized, double-blind, placebo-controlled
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AP-PA02
Arm Type
Experimental
Arm Description
Anti-pseudomonal bacteriophage
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Inactive isotonic solution
Intervention Type
Biological
Intervention Name(s)
AP-PA02
Intervention Description
Bacteriophage administered via inhalation
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Inactive Placebo administered via inhalation
Primary Outcome Measure Information:
Title
Incidence of Treatment Emergent Adverse Events (Safety and Tolerability) of single and multiple doses of AP-PA02 administered by inhalation
Description
Incidence and severity of treatment-emergent adverse events
Time Frame
Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug)
Secondary Outcome Measure Information:
Title
Part 2 (MAD) Only: Explore P. aeruginosa recovery in sputum following multiple doses of AP-PA02 administered by inhalation
Description
Change in P. aeruginosa colony-forming units (CFU) per gram of sputum
Time Frame
Baseline (Day -1) through 14 days post last dose of study drug

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mina Pastagia, MD, MS
Organizational Affiliation
Armata Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Children's Hospital Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
St. Luke's Cystic Fibrosis Center of Idaho
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60208
Country
United States
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
The University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Harper University Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Rutgers Robert Wood Johnson Medical School
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
New York Medical College
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Facility Name
The Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
University of Texas Southwestern
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792-9988
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://armatapharma.com
Description
Armata Pharmaceuticals, Inc.

Learn more about this trial

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

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