New allergy drug shows promise in early trial

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria (Phase 1): 1. Participant is willing to refrain from consuming food or beverages containing caffeine and/or xanthene products, within 24 hours prior to check-in on Day -1. 2. Female participants must be of non-child-bearing potential i.e., surgically sterilised at least 6 weeks before the screening visit or postmenopausal. Inclusion Criteria Phase Ib (Multiple Ascending Dose) 1. Minimum 2 year history of ragweed-induced AR requiring pharmacotherapy (self-reported history accepted) and a positive ragweed skin prick test reaction at Screening Visit. 2. Participant is willing to refrain from consuming food or beverages containing caffeine, within 24 hours prior to each clinic visit. 3. Female participants must be of non-child-bearing potential i.e., surgically sterilised or postmenopausal. Exclusion Criteria Phase I and Phase Ib (MAD): 1. Hypersensitivity or other clinically significant reaction to the study drug or its active ingredients. 2. Current treatment or use of any prescription medication within 14 days prior to admission to the clinic on Day -1 of active seasonal and perennial allergic rhinitis, non-allergic rhinitis, rhinosinusitis, or asthma. This includes antihistamines, asthma preventers and relievers, nasal decongestants, IN corticosteroids, and immunotherapy or use of over-the-counter medication/vitamins/supplements within 7 days prior to the first dose of study drug. Exceptions include contraception, paracetamol and standard doses of multivitamins. 3. Any clinically relevant structural nasal abnormalities, i.e., nasal septal perforation, nasal polyps, other nasal malformations or history of frequent nosebleeds, upper respiratory tract infection within 2 weeks prior to screening or first dose administration. 4. History of recurrent migraine headaches within 4 weeks prior to screening. 5. Positive alcohol breath, urine test, HBsAg, HepC virus antibody, or HIV antibody tests. 6. Participant has donated blood or blood products within 3 months prior to first dose administration. 7. Use of tobacco products or nicotine-containing products (including smoking cessation aids such as gum or patches. 8. Participant plans to travel to an area with known environmental ragweed exposures at any time during study participation.