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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 : December 17, 2020
Sponsor:
Collaborator:
Cystic Fibrosis Foundation
Information provided by (Responsible Party):
Armata Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE October 15, 2020
First Posted Date  ICMJE October 22, 2020
Last Update Posted Date December 17, 2020
Estimated Study Start Date  ICMJE December 2020
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 20, 2020)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 20, 2020)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ph 1/2 Study Evaluating Safety and Tolerability of Inhaled AP-PA02 in Subjects With Chronic Pseudomonas Aeruginosa Lung Infections and Cystic Fibrosis
Official Title  ICMJE 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
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 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized, double-blind, placebo-controlled
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Cystic Fibrosis
  • Pseudomonas Aeruginosa
  • Pseudomonas
  • Lung Infection
  • Lung Infection Pseudomonal
Intervention  ICMJE
  • Biological: AP-PA02
    Bacteriophage administered via inhalation
  • Other: Placebo
    Inactive Placebo administered via inhalation
Study Arms  ICMJE
  • Experimental: AP-PA02
    Anti-pseudomonal bacteriophage
    Intervention: Biological: AP-PA02
  • Placebo Comparator: Placebo
    Inactive isotonic solution
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 20, 2020)
48
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2022
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Vicki White, BS 310-633-4566 vwhite@armatapharma.com
Contact: Pierre Kyme, PhD 310-665-2928 ext 234 pkyme@armatapharma.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04596319
Other Study ID Numbers  ICMJE AP-PA02-101
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Armata Pharmaceuticals, Inc.
Study Sponsor  ICMJE Armata Pharmaceuticals, Inc.
Collaborators  ICMJE Cystic Fibrosis Foundation
Investigators  ICMJE
Study Director: Mina Pastagia, MD, MS Armata Pharmaceuticals, Inc.
PRS Account Armata Pharmaceuticals, Inc.
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP