Clinical study
SWARM-Pa
Ph 1/2 Study Evaluating Safety and Tolerability of Inhaled AP-PA02 in Subjects With Chronic Pseudomonas Aeruginosa Lung Infections and Cystic Fibrosis
| Status | Completed |
|---|---|
| Type | Trial |
| Countries | United States |
| Conditions studied | Cystic Fibrosis; Pseudomonas Aeruginosa; Pseudomonas; Lung Infection; Lung Infection Pseudomonal |
| Study years | 2020–2022 |
| Entry review | 2026-10-03 |
Participation
Check the study record or contact the study team for current recruitment and eligibility.
Study eligibility
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
Study description
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.
Study registrations
| ClinicalTrials.gov | NCT04596319 |
|---|
Recorded study locations (20)
Locations listed in the study record; this does not confirm current recruitment or treatment outside the study. A site label may be older than the overall study status.
Children's Hospital Los Angeles
Los Angeles, California, United States
Recorded site status: Not separately listed. Study location source ↗
University of South Florida
Tampa, Florida, United States
Recorded site status: Not separately listed. Study location source ↗
St. Luke's Cystic Fibrosis Center of Idaho
Boise, Idaho, United States
Recorded site status: Not separately listed. Study location source ↗
Northwestern University
Chicago, Illinois, United States
Recorded site status: Not separately listed. Study location source ↗
University of Iowa
Iowa City, Iowa, United States
Recorded site status: Not separately listed. Study location source ↗
The University of Kansas Medical Center
Kansas City, Kansas, United States
Recorded site status: Not separately listed. Study location source ↗
Johns Hopkins University
Baltimore, Maryland, United States
Recorded site status: Not separately listed. Study location source ↗
Massachusetts General Hospital
Boston, Massachusetts, United States
Recorded site status: Not separately listed. Study location source ↗
Boston Children's Hospital
Boston, Massachusetts, United States
Recorded site status: Not separately listed. Study location source ↗
Harper University Hospital
Detroit, Michigan, United States
Recorded site status: Not separately listed. Study location source ↗
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
Recorded site status: Not separately listed. Study location source ↗
New York Medical College
Valhalla, New York, United States
Recorded site status: Not separately listed. Study location source ↗
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Recorded site status: Not separately listed. Study location source ↗
Nationwide Children's Hospital
Columbus, Ohio, United States
Recorded site status: Not separately listed. Study location source ↗
The Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Recorded site status: Not separately listed. Study location source ↗
Medical University of South Carolina
Charleston, South Carolina, United States
Recorded site status: Not separately listed. Study location source ↗
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Recorded site status: Not separately listed. Study location source ↗
University of Texas Southwestern
Dallas, Texas, United States
Recorded site status: Not separately listed. Study location source ↗
University of Washington
Seattle, Washington, United States
Recorded site status: Not separately listed. Study location source ↗
University of Wisconsin
Madison, Wisconsin, United States
Recorded site status: Not separately listed. Study location source ↗
Related programs(1)
Armata Pharmaceuticals
Research/development
Recorded program–study link. Website
Sources and updates
Entry reviewed . This is the date of our source review, not a confirmation of availability today.
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| Study ID | nct04596319 |
|---|