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.
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).