Safety and Efficacy of AL-53817 Nasal Spray Solution

Stage A Inclusion Criteria:

• Willing and able to give written informed consent.
• In good health in the opinion of an appropriately qualified physician.
• Females of childbearing potential (who are not at least 1 year post-menopausal or surgically sterilized) must have a negative urine pregnancy test at Visit 1, and must not be nursing or plan to become pregnant during the course of the study.
• Other protocol-defined inclusion criteria may apply.

Stage B Inclusion Criteria:

• History of non-recalcitrant seasonal allergic rhinitis during the fall allergy season.
• Allergy to short ragweed allergen, defined by positive skin prick test for short ragweed allergen within the 12 months prior to Visit 1.
• Be in good health in the opinion of an appropriately qualified physician.
• Females of childbearing potential (who are not at least 1 year post-menopausal or surgically sterilized) must have negative urine pregnancy test at Visit 1, and must not be nursing or plan to become pregnant during the course of the study.
• Other protocol-defined inclusion criteria may apply.

Stage A Exclusion Criteria:

• Hypersensitivity to the study drug or any component of the test articles, including benzalkonium chloride.
• Using any prescription or non-prescription systemic or topical medications, vitamins or dietary supplements within 14 days prior to the check-in day (except for acetaminophen at doses of < 2 grams/day or topical, hormonal-oral, implantable or injectable contraceptives).
• Current or recent history of severe, unstable, or uncontrolled conditions based upon a review of medical history and/or physical examination.
• Any nasal disorder that could preclude safe administration of study medication and/or interfere with the evaluation of the study medication.
• History of HIV, hepatitis B or active hepatitis A as determined by medical history and/or by serology at the Screening Visit.
• Any screening clinical laboratory result (hematology, serum chemistry or urinalysis) outside the normal range that is clinically relevant in the opinion of an appropriately qualified physician and/or Alcon physician.
• Participation in any investigational study within 30 days of entry into this study or concomitantly with this study.
• Other protocol-defined exclusion criteria may apply.

Stage B Exclusion Criteria:

• Any screening clinical laboratory result (hematology, serum chemistry or urinalysis) outside the normal range that is clinically relevant in the opinion of an appropriately qualified physician and/or Alcon physician.
• Using any prescription or non-prescription systemic or topical medications, vitamins or dietary supplements within 14 days prior to the check-in day (except for acetaminophen at doses of < 2 grams/day or topical, hormonal-oral, implantable or injectable contraceptives).
• History of HIV, hepatitis B or C or active hepatitis A as determined by medical history and/or by serology at the Screening Visit.
• Any nasal disorder that could preclude safe administration of study medication and/or interfere with the evaluation of the study medication.
• Confirmed diagnosis of chronic rhinosinusitis within 12 months of Visit.
• Confirmed diagnosis of severe rhinitis or rhinosinusitis prior to Visit 1 that, in the opinion of the Investigator, would preclude safe subject participation in the study.
• Current or recent history of any severe, unstable, or uncontrolled condition that, in the opinion of the Investigator, would preclude safe participation in the study.
• Participation in any investigational study within 30 days of entry into this study or concomitantly with this study.
• Other protocol-defined exclusion criteria may apply.