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Virus Therapy

AP-PA02 for Cystic Fibrosis (SWARM-Pa Trial)

Phase 1 & 2
Waitlist Available
Research Sponsored by Armata Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
≥ 18 years old
Body mass index (BMI) of ≥ 18 kg/m2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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.
Awards & highlights

SWARM-Pa Trial Summary

This trialtests the safety and effects of inhaling a drug to fight lung infections in people with cystic fibrosis.

Eligible Conditions
  • Cystic Fibrosis
  • Pneumonia
  • Pseudomonal Lung Infection
  • Pseudomonas Infections
  • Pseudomonas Aeruginosa

SWARM-Pa Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

SWARM-Pa Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence and Severity Treatment Emergent Adverse Events (TEAEs)
Secondary outcome measures
Part 2 (MAD) Only: Explore P. aeruginosa recovery in sputum following multiple doses of AP-PA02 administered by inhalation

Side effects data

From 2022 Phase 1 & 2 trial • 29 Patients • NCT04596319
50%
headache
50%
Backache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Amendment 5 MAD
Cohort 1 SAD
Cohort 2 SAD
SAD Placebo
Cohort 3 MAD
Cohort 4 MAD
MAD Placebo

SWARM-Pa Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: AP-PA02Experimental Treatment1 Intervention
Anti-pseudomonal bacteriophage
Group II: PlaceboPlacebo Group1 Intervention
Inactive isotonic solution
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AP-PA02
2020
Completed Phase 2
~30

Find a Location

Who is running the clinical trial?

Armata Pharmaceuticals, Inc.Lead Sponsor
12 Previous Clinical Trials
516 Total Patients Enrolled
Cystic Fibrosis FoundationOTHER
187 Previous Clinical Trials
36,334 Total Patients Enrolled
180 Trials studying Cystic Fibrosis
33,397 Patients Enrolled for Cystic Fibrosis
Mina Pastagia, MD, MSStudy DirectorArmata Pharmaceuticals, Inc.
2 Previous Clinical Trials
308 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities for enrollment in this experiment currently?

"As recorded on clinicaltrials.gov, this experiment is actively recruiting participants to participate in the study which was posted and last updated respectively on December 22nd 2020 and November 24th 2021."

Answered by AI

What is the scope of this experiment in terms of participating locations?

"The trial is available at 17 locations throughout the country, including Boston, Chicago and Iowa City. It is suggested that patients pick a site close to them in order to limit transportation costs for participants."

Answered by AI

How many participants is the clinical trial limited to?

"Armata Pharmaceuticals, Inc. is the primary sponsor of this clinical trial and will be running it from Boston Children's Hospital in MA as well as Northwestern University in IL. For the investigation to commence 48 qualifying individuals are necessary."

Answered by AI
~7 spots leftby Mar 2025