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NCT04596319 · ClinicalTrials.gov registry record · Phase 1
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 study, sponsored by Armata Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 29
- Enrollment target
NCT04596319: Completed Phase 1 study, sponsored by Armata Pharmaceuticals.
NCT04596319 is a Phase 1 study that has completed, run by Armata Pharmaceuticals. The registered enrollment target is 29 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04596319, a Phase 1 study, has completed, sponsored by Armata Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 29 participants
- Enrollment target
Study 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.
Primary Outcome
Incidence and severity of treatment emergent adverse events of single and multiple doses of AP-PA02 administered by inhalation
Interventions
- OTHER Placebo
- BIOLOGICAL AP-PA02
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2020-12-22 |
| Est. Completion | 2022-12-14 |
| Phase | Phase 1 |
What the finished NCT04596319 record still lists
NCT04596319 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04596319 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04596319 about?
NCT04596319 is a clinical study titled "Ph 1/2 Study Evaluating Safety and Tolerability of Inhaled AP-PA02 in Subjects With Chronic Pseudomonas Aeruginosa Lung Infections and Cystic Fibrosis". 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 P...
What is the current status of trial NCT04596319?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 29 participants. The study started on 2020-12-22. Estimated completion is 2022-12-14.
What interventions are being tested in trial NCT04596319?
The interventions under investigation include: Placebo (OTHER), AP-PA02 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04596319?
This trial is sponsored by Armata Pharmaceuticals, which has 11 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04596319's enrollment target sits among peer trials
29 1440th of 2000 higher than 554 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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