Programs and studies

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

StatusCompleted
TypeTrial
CountriesUnited States
Conditions studiedCystic Fibrosis; Pseudomonas Aeruginosa; Pseudomonas; Lung Infection; Lung Infection Pseudomonal
Study years2020–2022
Entry review2026-10-03

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.govNCT04596319
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)

Sources and updates

Entry reviewed . This is the date of our source review, not a confirmation of availability today.

AI helped us research this directory. Details may be wrong or out of date. Confirm availability with the clinic or study team. Suggest a correction.

Study ID
nct04596319