Safety and Dose Finding Trial of BM32 in Subjects Suffering From Grass Pollen Allergy

This is an interventional treatment trial for Grass Pollen Allergy focused on measuring grass pollen allergy, immunotherapy, recombinant vaccine Read More

Inclusion Criteria:

• History of seasonal allergic rhinitis from grass pollen
• Normal electrocardiogram
• Moderate to severe response to approx. 1500 grass pollen grains/m3 after 2 hrs of exposure in challenge chamber
• Positive skin prick test for grass pollen at or within 12 months preceding screening visit
• Positive RAST (class 2 or higher) for timothy grass pollen and to rPhl p 1 + rPhl p 5 at or within 12 months preceding screening visit

Exclusion Criteria:

• Pregnant or lactating females
• Females with childbearing potential not using medically acceptable birth control
• Structural nasal abnormalities, nasal polyposis, history of frequent nosebleeds, recent nasal surgery or ongoing upper respiratory tract infection
• Any respiratory disease other than mild asthma controlled with occasional short acting beta agonists and normal lung function
• Current or recent participation in another clinical trial
• SIT for grass pollen allergy in the last two years prior to study
• Past or present disease, which may affect outcome of the trial, judged by investigator
• Autoimmune diseases, immune defects including immunosuppression, immune- complex immunopathies
• Suspected hypersensitivity to any ingredients of study medication
• Use of prohibited medication prior to screening and throughout study
• depot corticosteroids (12 weeks)
• oral corticosteroids (8 weeks)
• inhaled corticosteroids (4 weeks)
• Allergic symptoms at the time of screening