A Single Centre, Double-blind, Randomised Study To Investigate a Single Oral Dose of IMD-1041 in A Nasal Allergen Challenge (NAC) Model

INTERVENTION: Product Name: IMD‐1041 Product Code: IMD‐1041 Pharmaceutical Form: Capsule Current Sponsor code: IMD‐10412002‐1 Other descriptive name: N‐[3,5‐Bis(trifluoromethyl)phenyl]‐5‐chloro‐ Concentration unit: mg milligram(s) Concentration type: up to Concentration number: 100‐ Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use CONDITION: It is intended to investigate the potential therapeutic benefit of IKKß inhibition in man by oral dosing of IMD‐1041 in a Nasal Alllergen Challenge. ; MedDRA version: 14.1 Level: PT Classification code 10053467 Term: Antiinflammatory therapy System Organ Class: 10042613 ‐ Surgical and medical procedures Therapeutic area: Diseases [C] ‐ Ear, nose and throat diseases [C09] PRIMARY OUTCOME: Main Objective: To investigate the potential therapeutic benefit of IKKß inhibition in man by oral dosing of IMD‐1041 in NAC model. To evaluate safety, efficacy and effects on key pathological parameters of IMD‐1041 in patients with allergic rhinitis due to grass pollen (hayfever). Primary end point(s): Determination of safety, efficacy and potential therapeutic benefit of IKKB inhibition in man by oral dosing of IMD‐1041. Secondary Objective: To investigate the effects of IMD‐1041 on NF‐?B inhibition ex vivo. INCLUSION CRITERIA: Healthy male, non‐smoking subjects aged between 18 and 60 years inclusive, and in good health as determined by past medical history, physical examination, vital signs, ECG and laboratory tests at screening. A history of symptoms of seasonal grass pollen related allergic rhinitis in the previous two years. In the UK, this involves nasal symptoms between June and August Allergy defined by a positive skin prick test response to Timothy grass pollen, with a wheal of diameter = 3mm larger than the negative control response. This may have been detected on skin testing at any time in the past 12 months. Lack of nasal symptoms suggestive of allergic rhinitis in the 3 days before each study visit. Normal appearing nasal mucosa with no active allergic rhinitis on screening Spirometry testing: forced expiratory volume in 1 second (FEV1) within normal limits (= 80 % predicted) Normal findings on clinical examination on screening. A subject with a clinical abnormality may