At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 63 enrolled
Drug / intervention
AZD5634 for inhalation +2 moredrug
Likely dose
AZD5634 for inhalation 5 mgfrom 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 I, Randomized, Single-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD5634 Following Single-Ascending Inhaled Doses (Part A) and After Single Inhaled and Intravenous Doses (Part B) in Healthy Subjects
In Brief
A Phase 1 clinical trial evaluating AZD5634 for inhalation, AZD5634 for infusion, and 1 other intervention for Cystic Fibrosis. Completed, enrolled 63 participants across 2 sites.
Detailed Summary
This is a Phase 1, first-in-human (FIH) single ascending dose study being conducted to better understand the safety, tolerability and pharmacokinetics of AZD5634 in healthy subjects
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedFeb 2016
Enrollment StartFeb 2016
Primary CompletionOct 2016
TodayJul 2026
First PostedFeb 10, 2016
Enrollment StartFeb 11, 2016
Primary CompletionOct 24, 2016
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 10.4 years ago
Interventions
AZD5634 for inhalationdrug
Solution, citrate buffer, saline nebulizer solution; strength 0.1 - 5 mg/g; administered by jet nebulizer
AZD5634 for infusiondrug
Solution, citrate buffer, saline solution for infusion; strength 0.013 mg/mL
Placeboother
inactive substance