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

Recruitment Status : Recruiting

First Posted : October 22, 2020

Last Update Posted : December 17, 2020

See Contacts and Locations

Sponsor:

Collaborator:

Cystic Fibrosis Foundation

Information provided by (Responsible Party):

Armata Pharmaceuticals, Inc.

Tracking Information

First Submitted Date ^ICMJE

October 15, 2020

First Posted Date ^ICMJE

October 22, 2020

Last Update Posted Date

December 17, 2020

Estimated Study Start Date ^ICMJE

December 2020

Estimated Primary Completion Date

March 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

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 ^ICMJE

Interventional

Study Phase ^ICMJE

Phase 1
Phase 2

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Randomized, double-blind, placebo-controlled

Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Cystic Fibrosis
Pseudomonas Aeruginosa
Pseudomonas
Lung Infection
Lung Infection Pseudomonal

Intervention ^ICMJE

Biological: AP-PA02
Bacteriophage administered via inhalation
Other: Placebo
Inactive Placebo administered via inhalation

Study Arms ^ICMJE

Experimental: AP-PA02
Anti-pseudomonal bacteriophage

Intervention: Biological: AP-PA02
Placebo Comparator: Placebo
Inactive isotonic solution

Intervention: Other: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date ^ICMJE

March 2022

Estimated Primary Completion Date

March 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact: Vicki White, BS	310-633-4566	vwhite@armatapharma.com
Contact: Pierre Kyme, PhD	310-665-2928 ext 234	pkyme@armatapharma.com

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT04596319

Other Study ID Numbers ^ICMJE

AP-PA02-101

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product:	Yes
Studies a U.S. FDA-regulated Device Product:	No

IPD Sharing Statement ^ICMJE

Plan to Share IPD:

Responsible Party

Armata Pharmaceuticals, Inc.

Study Sponsor ^ICMJE

Armata Pharmaceuticals, Inc.

Collaborators ^ICMJE

Cystic Fibrosis Foundation

Investigators ^ICMJE

Study Director:

Mina Pastagia, MD, MS

Armata Pharmaceuticals, Inc.

PRS Account

Armata Pharmaceuticals, Inc.

Verification Date

December 2020

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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