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 |
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Recruitment Status :
Recruiting
First Posted : October 22, 2020
Last Update Posted : December 17, 2020
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Sponsor:
Armata Pharmaceuticals, Inc.
Collaborator:
Cystic Fibrosis Foundation
Information provided by (Responsible Party):
Armata Pharmaceuticals, Inc.
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cystic Fibrosis Pseudomonas Aeruginosa Pseudomonas Lung Infection Lung Infection Pseudomonal | Biological: AP-PA02 Other: Placebo | Phase 1 Phase 2 |
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 : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 48 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Randomized, double-blind, placebo-controlled |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | 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 |
| Estimated Study Start Date : | December 2020 |
| Estimated Primary Completion Date : | March 2022 |
| Estimated Study Completion Date : | March 2022 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Cystic fibrosis
MedlinePlus related topics:
Cystic Fibrosis
Drug Information available for:
Pseudomonas aeruginosa
| Arm | Intervention/treatment |
|---|---|
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Experimental: AP-PA02
Anti-pseudomonal bacteriophage
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Biological: AP-PA02
Bacteriophage administered via inhalation |
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Placebo Comparator: Placebo
Inactive isotonic solution
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Other: Placebo
Inactive Placebo administered via inhalation |
Primary Outcome Measures :
- 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
Secondary Outcome Measures :
- 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
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04596319
Contacts
| Contact: Vicki White, BS | 310-633-4566 | vwhite@armatapharma.com | |
| Contact: Pierre Kyme, PhD | 310-665-2928 ext 234 | pkyme@armatapharma.com |
Locations
| United States, California | |
| Children's Hospital Los Angeles | Recruiting |
| Los Angeles, California, United States, 90027 | |
| Contact: Carmen Reyes mareyes@chla.usc.edu | |
| Principal Investigator: Thomas Keens, MD | |
| United States, Idaho | |
| St. Luke's Cystic Fibrosis Center of Idaho | Recruiting |
| Boise, Idaho, United States, 83712 | |
| Contact: Lejla Godusevic 208-381-4717 godusevl@slhs.org | |
| Principal Investigator: Perry Brown, MD, FAAP | |
| United States, Massachusetts | |
| Boston Children's Hospital | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Robert Fowler Robert.Fowler@childrens.harvard.edu | |
| Principal Investigator: Henry Dorkin, MD | |
| United States, Tennessee | |
| Vanderbilt University Medical Center | Recruiting |
| Nashville, Tennessee, United States, 37232 | |
| Contact: Brijesh Patel Brijesh.Patel@vumc.org | |
| Contact: James J Tolle, MD James.J.Tolle@vanderbilt.edu | |
| Principal Investigator: James J Tolle, MD | |
| United States, Texas | |
| University of Texas Southwestern | Recruiting |
| Dallas, Texas, United States, 75390 | |
| Contact: Ashley Keller ashley.keller@utsouhtwestern.edu | |
| Contact: Raksha Jain, MD Raksha.Jain@UTSouthwestern.edu | |
| Principal Investigator: Raksha Jain, MD | |
Sponsors and Collaborators
Armata Pharmaceuticals, Inc.
Cystic Fibrosis Foundation
Investigators
| Study Director: | Mina Pastagia, MD, MS | Armata Pharmaceuticals, Inc. |
Additional Information:
| Responsible Party: | Armata Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT04596319 |
| Other Study ID Numbers: |
AP-PA02-101 |
| First Posted: | October 22, 2020 Key Record Dates |
| Last Update Posted: | December 17, 2020 |
| Last Verified: | December 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Armata Pharmaceuticals, Inc.:
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phage bacteriophage cystic fibrosis Pseudomonas Pseudomonas aeruginosa |
Additional relevant MeSH terms:
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Infection Communicable Diseases Pseudomonas Infections Cystic Fibrosis Fibrosis Pathologic Processes Pancreatic Diseases |
Digestive System Diseases Lung Diseases Respiratory Tract Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Gram-Negative Bacterial Infections Bacterial Infections |