Tolerability and Potential Efficacy of AD17002 in Subjects With Allergic Rhinitis

Exclusion Criteria

• •1. Has a clinically relevant, known history of symptomatic allergic rhinoconjunctivitis and/or asthma caused by mold, animal hair and dander, or other allergens (except HDM) to which the subject is regularly exposed and sensitized. Subjects without a known history of allergy other than to HDM, but show any positive result (on CAP test) towards the allergens could be accepted in the judgement of the investigator.
• •2. Has any nasal condition that, in the judgement of the investigator, could confound the efficacy or safety assessments (e.g., nasal polyposis, nasal malformation, frequent nosebleeds, etc).
• •3. Has a history of anaphylaxis reaction to any known or unknown cause.
• •4. Has a history of chronic urticaria and/or angioedema within the last 2 years before Screening Visit.
• •5. Immunosuppressed subjects as result of illness (e.g. HIV infection) or treatment.
• •6. Has acute respiratory illness needing antibiotics or antivirals within 14 days prior to the Screening visit.
• •7. Has acute sinusitis or chronic sinusitis accompanying acute symptoms within 3 days prior to administration of first dose of study drug.
• •8. Has any clinically relevant chronic disease (≥3 months duration) \[including but not limited to cystic fibrosis, malignancy, type I diabetes mellitus, malabsorption or malnutrition, renal or hepatic insufficiency, rheumatic arthritis, lupus and other autoimmune diseases\].
• •9. Has documented history of Bell's palsy.
• •10. Has a history of allergic reaction to kanamycin.
• •11. Has received Immunosuppressive treatment (ATC code L04 or L01) within 3 months prior to the Screening visit.
• •12. Has had previous immunotherapy treatment with any HDM allergen.
• •13. Has had previous exposure to the study drug or Flu Vaccine AD07030.
• •14. Is receiving ongoing treatment with any specific immunotherapy at the time of the Screening Visit.
• •15. Has a known history of allergy (except HDM), hypersensitivity, or intolerance to investigational medicinal products, rescue medications, or self-injectable epinephrine.
• •16. Subjects with chronic (\> 6 months) or intermittent dependence on nasal, inhaled, oral, intramuscular, intravenous corticosteroids, or potent topical corticosteroids with systemic effects. Subjects who are non-chronic users and do not use these corticosteroids intermittently must undergo at least 5 half-lives of washout prior to the Screening visit.
• •17. Subjects using other medications for their allergic rhinitis and/or asthma if they cannot abstain from the specified time window below (or 5 half-lives, whichever is longer) prior to the Screening visit:
• •* Nasal or oral antihistamines: 48 hours
• •* Nasal decongestants: 24 hours
• •* Oral decongestants: 24 hours
• •* Short acting inhaled beta-agonists: 48 hours
• •* Long acting antihistamine (half-life \>24hrs): 10 days
• •18. Subjects who had chronic use (\> 6 months) of concomitant medications \[e.g., tricyclic antidepressants, beta-blocker, xanthines (including theophylline, but not including caffeine), anticholinergics, cromoglycates, leukotriene antagonists, 5-lipoxygenase inhibitors and long-acting inhaled beta-agonists, etc\] that would affect assessment of the effectiveness of the investigational product. Subjects who are non-chronic users of these medications must undergo at least 5 half-lives of washout prior to the Screening visit.
• •19. Is nursing at randomization and within the projected duration of the trial.
• •20. Subject who plans travel outside the trial area for a substantial portion of the trial period.
• •21. Other cases judged by the investigator to be ineligible for participation in the study.