At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 29 enrolled
Drug / intervention
AP-PA02 +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating AP-PA02 and Placebo for Cystic Fibrosis and 4 related conditions. Completed, enrolled 29 participants across 20 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis, Pseudomonas Aeruginosa, Pseudomonas, Lung Infection, Lung Infection Pseudomonal
CountriesUnited States
CollaboratorsCystic Fibrosis Foundation
Timeline
Phase 2CompletedFinished
202120222023202420252026
First PostedOct 2020
Enrollment StartDec 2020
Primary CompletionDec 2022
TodayJul 2026
First PostedOct 22, 2020
Enrollment StartDec 22, 2020
Primary CompletionDec 14, 2022
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 5.7 years ago
Interventions
AP-PA02biological
Bacteriophage administered via inhalation
Placeboother
Inactive Placebo administered via inhalation