At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 16 enrolled
Drug / intervention
PT001 +3 moredrug
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 Randomized, Double-blind, Single Dose, Four-period, Four-treatment, Cross-over Study Evaluating the Safety of PT001, PT003, PT005 Administered Individually and PT001 + PT005 Delivered Together in Separate Inhalers in Healthy Subjects
In Brief
A Phase 1 clinical trial evaluating PT001, PT005, and 2 other interventions for Healthy Volunteers. Completed, enrolled 16 participants across 1 site.
Detailed Summary
The purpose of this study is to evaluate the safety of a single dose of PT003 compared with single doses of PT001 and PT005, and compared with PT001 plus PT005 delivered together as two separate single doses in healthy subjects.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers
CountriesAustralia
Collaborators--
Timeline
Phase 1CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMay 2009
First PostedMay 2009
Primary CompletionJul 2009
TodayJul 2026
First PostedMay 6, 2009
Enrollment StartMay 1, 2009
Primary CompletionJul 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 17.2 years ago
Interventions
PT001drug
Inhaled PT001, single dose
PT005drug
Inhaled PT005, single dose
PT003drug
Inhaled PT003, single dose
PT001 + PT005drug
Inhaled PT001 + PT005, single dose