Cystic FibrosisPhase 1/2SWARM-PaNCT04596319
Ph 1/2 Study Evaluating Safety and Tolerability of Inhaled AP-PA02 in Subjects With Chronic Pseudomonas Aeruginosa Lung Infections and Cystic Fibrosis
A Phase 1/2 study testing AP-PA02 in people with Cystic Fibrosis and Pseudomonas Aeruginosa, run by Armata Pharmaceuticals, Inc. at 20 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis, Pseudomonas Aeruginosa, Pseudomonas
- What is being tested?
- AP-PA02
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 20 sitesUnited States
- Study dates
- 22 Dec 2020to 14 Dec 2022
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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
Who cannot join
- 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.
Show all 18Show fewer
- 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
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Johns Hopkins University
Baltimore, Maryland, 21205
St. Luke's Cystic Fibrosis Center of Idaho
Boise, Idaho, 83712
Massachusetts General Hospital
Boston, Massachusetts, 02114
Boston Children's Hospital
Boston, Massachusetts, 02115
Medical University of South Carolina
Charleston, South Carolina, 29425
Northwestern University
Chicago, Illinois, 60208
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Nationwide Children's Hospital
Columbus, Ohio, 43205
University of Texas Southwestern
Dallas, Texas, 75390
Harper University Hospital
Detroit, Michigan, 48201
University of Iowa
Iowa City, Iowa, 52242
The University of Kansas Medical Center
Kansas City, Kansas, 66160
Children's Hospital Los Angeles
Los Angeles, California, 90027
University of Wisconsin
Madison, Wisconsin, 53792-9988
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901
The Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Washington
Seattle, Washington, 98195
University of South Florida
Tampa, Florida, 33606
New York Medical College
Valhalla, New York, 10595
About this study
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
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.
Read the 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 two ascending dose levels, administered by inhalation. Treatment assignment will be randomized, double-blind, placebo-controlled in each of two 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 two 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.
- Conditions
- Cystic Fibrosis, Pseudomonas Aeruginosa, Pseudomonas, Lung Infection, Lung Infection Pseudomonal
- Being tested
- AP-PA02, Placebo
- Keywords
- phage, bacteriophage, cystic fibrosis, Pseudomonas, Pseudomonas aeruginosa
- Medical subject headings
- Cystic Fibrosis, Pseudomonas Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AP-PA02Biological
Bacteriophage administered via inhalation
PlaceboOther
Inactive Placebo administered via inhalation
| Study group | Role | What they receive |
|---|---|---|
| AP-PA02 | Experimental | Anti-pseudomonal bacteriophage Receives: Biological: AP-PA02 |
| Placebo | Placebo comparator | Inactive isotonic solution Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and Severity Treatment Emergent Adverse Events (TEAEs)
Incidence and severity of treatment emergent adverse events of single and multiple doses of AP-PA02 administered by inhalation
Measured: Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start22 Dec 2020
- Primary completion14 Dec 2022
- Study completion14 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, placebo-controlled
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Armata Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cystic Fibrosis Foundation
- Responsible party
- Sponsor
- Investigators
- Mina Pastagia, MD, MS, Study director, Armata Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04596319
- Sponsor's protocol ID
- AP-PA02-101
- Acronym
- SWARM-Pa
- Status last verified
- Jan 2024
- First submitted
- 15 Oct 2020
- Last updated
- 31 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04596319
- Acronym / sponsor ID
- SWARM-Pa / AP-PA02-101
- Conditions
- Cystic Fibrosis, Pseudomonas Aeruginosa, Pseudomonas, Lung Infection, Lung Infection Pseudomonal
- Keywords
- phage, bacteriophage, cystic fibrosis, Pseudomonas, Pseudomonas aeruginosa
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Armata Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Cystic Fibrosis Foundation
- Study start
- 22 Dec 2020 (actual)
- Primary completion
- 14 Dec 2022 (actual)
- Study completion
- 14 Dec 2022 (actual)
- First posted
- 22 Oct 2020 (actual)
- Results
- Posted 31 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 two ascending dose levels, administered by inhalation. Treatment assignment will be randomized, double-blind, placebo-controlled in each of two 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 two 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomized, double-blind, placebo-controlled
| Arm | Type | Receives |
|---|---|---|
| AP-PA02 | Experimental | Biological: AP-PA02Anti-pseudomonal bacteriophage |
| Placebo | Placebo comparator | Other: PlaceboInactive isotonic solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- ≥ 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)
Key exclusion criteria (18 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AP-PA02Bacteriophage administered via inhalation | Biological | AP-PA02 |
| PlaceboInactive Placebo administered via inhalation | Other | Placebo |
Primary outcome
Incidence and Severity Treatment Emergent Adverse Events (TEAEs)
Time frame: Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose.
Incidence and severity of treatment emergent adverse events of single and multiple doses of AP-PA02 administered by inhalation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Armata Pharmaceuticals, Inc.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mina Pastagia, MD, MS study director
Armata Pharmaceuticals, Inc.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AP-PA02 in people with Cystic Fibrosis and Pseudomonas Aeruginosa, run by Armata Pharmaceuticals, Inc. at 20 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and Severity Treatment Emergent Adverse Events (TEAEs) (time frame: Day 1 pre-dose through End of Study Visit (28 days post last dose of study drug), up to 4 weeks for single ascending dose and up to 5.5 weeks for multiple ascending dose.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2024.