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

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Cystic Fibrosis, Pseudomonas Aeruginosa, Pseudomonas, Lung Infection, Lung Infection Pseudomonal

In brief

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.

Key facts

Study ID

NCT04596319

Run by

Armata Pharmaceuticals, Inc.

People needed

29

Starts

2020-12-22

Expected to finish

2022-12-14

Last updated by the study team

2024-01-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

Where it is running

• Children's Hospital Los Angeles — Los Angeles, California, United States
• University of South Florida — Tampa, Florida, United States
• St. Luke's Cystic Fibrosis Center of Idaho — Boise, Idaho, United States
• Northwestern University — Chicago, Illinois, United States
• University of Iowa — Iowa City, Iowa, United States
• The University of Kansas Medical Center — Kansas City, Kansas, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Boston Children's Hospital — Boston, Massachusetts, United States
• Harper University Hospital — Detroit, Michigan, United States
• Rutgers Robert Wood Johnson Medical School — New Brunswick, New Jersey, United States
• New York Medical College — Valhalla, New York, United States
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States
• The Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• University of Texas Southwestern — Dallas, Texas, United States
• University of Washington — Seattle, Washington, United States
• University of Wisconsin — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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