At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 25 enrolled
Drug / intervention
AeroVanc +1 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.
Phase I, Reference-controlled, Dose Escalating Study to Examine the Pharmacokinetics and Safety of AeroVanc Inhalation Powder.
In Brief
A Phase 1 clinical trial evaluating AeroVanc and IV vancomycin hydrochloride for Healthy and Cystic Fibrosis. Completed, enrolled 25 participants across 2 sites.
Detailed Summary
The study is carried out to evaluate the safety, tolerability and pharmacokinetics of AeroVanc inhalation powder in healthy volunteers, and in patients with cystic fibrosis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy, Cystic Fibrosis
CountriesAustralia
CollaboratorsINC Research Limited
Timeline
Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartNov 2011
First PostedFeb 2012
Primary CompletionMar 2012
TodayJul 2026
First PostedFeb 23, 2012
Enrollment StartNov 1, 2011
Primary CompletionMar 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 14.4 years ago
Interventions
AeroVancdrug
Vancomycin hydrochloride dry powder for inhalation
IV vancomycin hydrochloridedrug
Vancomycin hydrochloride solution for intravenous administration