Safety and Efficacy of AL-53817 Nasal Spray Solution
Condition: Nasal Allergies; Allergies
MeSH terms: Hypersensitivity
Intervention: AL-53817 nasal spray solution; Vehicle nasal spray
Intervention description: 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.; Inactive ingredients used as placebo comparator during Stage A and Stage B.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 110.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Healthy subjects; Nasal allergies; Allergies; Environmental Exposure Chamber; EEC; Ragweed

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).
    

Eligibility criteria:

        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.