At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 110 enrolled
Drug / intervention
AL-53817 nasal spray solution +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.
Safety and Efficacy of AL-53817 Nasal Spray Solution in Ragweed Sensitive Subjects in an Environmental Exposure Chamber (EEC)
In Brief
A Phase 1 clinical trial evaluating AL-53817 nasal spray solution and Vehicle nasal spray for Nasal Allergies and Allergies. Completed, enrolled 110 participants across 1 site.
Detailed Summary
The purpose of this study was to determine the maximum tolerated dose of AL-53817 (Stage A) and evaluate the safety and efficacy of AL-53817 for the treatment of allergic rhinitis (Stage B).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNasal Allergies, Allergies
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartOct 2011
First PostedOct 2011
Primary CompletionMar 2012
TodayJul 2026
First PostedOct 19, 2011
Enrollment StartOct 1, 2011
Primary CompletionMar 1, 2012
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 14.7 years ago
Interventions
AL-53817 nasal spray solutiondrug
Active ingredients administered in 1 of 3 concentrations during Stage A to determine maximum tolerated dose (MTD), and administered at maximum tolerated dose during Stage B.
Vehicle nasal sprayother
Inactive ingredients used as placebo comparator during Stage A and Stage B.