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Study to Evaluate the Safety, Phage Kinetics, and Efficacy of Inhaled AP-PA02 in Subjects With Non-Cystic Fibrosis Bronchiectasis and Chronic Pulmonary Pseudomonas Aeruginosa Infection
Study Purpose
A phase 2, multi-center, double-blind, randomized, placebo-controlled study to evaluate the
safety, phage kinetics, and efficacy of inhaled AP-PA02 administered in subjects with
non-cystic fibrosis bronchiectasis and chronic pulmonary Pseudomonas aeruginosa infection.
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
No
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
Interventional
Eligible Ages
18 Years and Over
Gender
All
More Inclusion & Exclusion Criteria
Key
Inclusion Criteria:
- ≥ 18 years old.
- Body mass index (BMI) of ≥ 18 kg/m2.
- Evidence of bronchiectasis per CT.
- 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 ≥ 35% of predicted normal [per Global Lung Function Initiative (GLI) standards]
at Screening.
- For Cohort A: have not received chronic inhaled antipseudomonal antibiotics regimen
for at least 3 months prior to Visit 1.
- For Cohort B: have received chronic inhaled antipseudomonal antibiotics regimen for at
least 3 months prior to Visit 1.
Key
Exclusion Criteria:
- Abnormal vital signs at Screening.
- History of lung transplantation.
- History of cystic fibrosis.
- History of α1-antitrypsin deficiency.
- History of primary or acquired immunodeficiency syndromes.
- History of COPD.
- History of pulmonary malignancy or any other malignancy requiring treatment.
- History of prolonged QT syndrome.
- History of hemoptysis.
- Recent significant weight loss.
- Recent use of supplemental oxygen during the day while at rest.
- Recent use of cigarettes, cigars, or pipes, or used tobacco or other nicotine source
by vaping.
- Recent changes in either the treatment regimen or initiation of treatment with: oral
macrolides, hypertonic saline, mucolytics, bronchodilator medications, or oral
corticosteroids.
- Currently receiving treatment for active infection at any site.
- Female pregnant of breastfeeding
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Phase 2
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
Armata Pharmaceuticals, Inc.
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study.
Mina Pastagia, MD
Principal Investigator Affiliation
Armata Pharmaceuticals, Inc.
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
Industry
Overall Status
Recruiting
Countries
United States
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied.
This study will be conducted in two cohorts running in parallel: Cohort A will evaluate the
safety, tolerability, and efficacy of inhaled AP-PA02 in subjects who have not received an
antipseudomonal inhaled antibiotic for a minimum of 3 months prior. Cohort B will evaluate
the safety, tolerability, and efficacy of inhaled AP-PA02 in subjects who have received an
antipseudomonal inhaled antibiotic for a minimum of 3 months prior. Subjects in both Cohorts
A and B will be followed for approximately 4 weeks after last dose of study drug and
evaluated for safety, tolerability, and efficacy.
Arms & Interventions
Arms
Experimental: AP-PA02
Anti-pseudomonal bacteriophage
Placebo Comparator: Placebo
Inactive isotonic solution
Interventions
Biological: - AP-PA02
Bacteriophage administered via inhalation
Other: - Placebo
Inactive Placebo administered via inhalation
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
