Proof of Activity Study of UR-63325 in Allergic Rhinitis Induced by Nasal Challenge

Inclusion Criteria:

• Provision of written informed consent to participate (prior to any study-relatedprocedures being performed) as shown by a signature on the volunteer consent form andto be able to adhere to the study restrictions and examination schedule

• Subjects with confirmed history of seasonal allergic rhinitis to grass pollen (bydirect questioning of presence of positive skin prick test to pollen and History ofSymptoms of allergic rhinitis) within the previous two years

• Positive skin prick test to timothy grass pollen (wheal difference with negativecontrol ≥ 3 mm) at screening

• Subjects with positive response to screening nasal challenge with increasing doses oftimothy grass pollen (Symptoms worsening with respect to the response to the diluentchallenge of ≥4 points in the total nasal symptom score [TNSS]) within one hour afterlast nasal allergen challenge

• Screening and baseline FEV1 >80% predicted and FEV1/FVC > 70% predicted

Exclusion Criteria:

• Symptoms of allergic rhinitis within 2 weeks prior to screening

• Upper respiratory infection or sinusitis within 14 days of screening and also within 14 days of study start in each of the two periods

• Structural nasal abnormalities or nasal polyps on examination, a history of nosebleeding or recent nasal surgery

• History of asthma or asthmatic symptoms or other respiratory disease other thanrhinitis within the last 2 years or FEV1<80% of predicted at screening or baseline