Safety and Efficacy of AL-53817 Nasal Spray Solution

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Alcon Research
• Treatments: Pharmaceutical Solutions

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.