Allergies Clinical Trial
Official title:
Safety and Efficacy of AL-53817 Nasal Spray Solution in Ragweed Sensitive Subjects in an Environmental Exposure Chamber (EEC)
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).
Stage A was a 1-day, single ascending dose study utilizing 7 separate cohorts of unique
subjects (healthy normal volunteers). Each cohort was administered a different dose of
AL-53817 Nasal Spray Solution in order to determine the maximum tolerated dose (MTD).
In Stage B, 2 different cohorts of unique, ragweed-sensitive subjects were administered the
MTD for up to 5 days twice a day to determine the safety and efficacy of AL-53817 Nasal
Spray Solution for the treatment of allergic rhinitis. Subjects were required to meet
minimum allergic rhinitis scores at two qualifying EEC visits to participate in the study.
Subjects were continually housed in clinic during the 5-day treatment period.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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