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

• Conditions: 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: 14.1Level: PTClassification code 10053467Term: Antiinflammatory therapySystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]

• Registration Number: EUCTR2007-000190-28-GB
• Lead Sponsor: Institute of Medicinal Molecular Design Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02-23
• Last Update Posted: 26 June 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 12

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 be included only if the Principal investigator considers that the abnormality will not introduce additional risk factors and will not interfere with the study procedures. Normal laboratory findings on screening. Subjects with laboratory parameters outside the reference range for this age group will only be included if the Principal Investigator considers that such findings will not introduce additional risk factors, or interfere with study procedures. Normal 12-Lead electrocardiogram (ECG) on screening. Read, comprehend and write English at a sufficient level to complete study related materials. Able to give written informed consent prior to participation in the study, which includes ability to comply with the requirements and restrictions in the consent form.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Smokers that use tobacco products in the past 3 months. Signs or symptoms of rhinitis at the time of study entry. Nasal conditions likely to affect the outcome of the study, i.e. nasal septal perforations, nasal polyps, sinus disease, chronic nasal obstruction, or other nasal diseases. Presence of any respiratory diseases other than mild stable asthma not requiring treatment. Clinical features suspicious of tuberculosis – weight loss, pyrexia, haemoptysis cough with purulent sputum Infection of the upper airways or lower airways, sinus, or ear, including viral infections in the 14 days prior to screening and throughout study visits A history of hypersensitivity/anaphylaxis to any of the challenge agents employed in this study FEV1= 70% predicted prior to each nasal challenge Subjects with a positive exhaled carbon monoxide test. Positive urine drug screen at pre-study medical History of abuse of alcohol, defined as an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units for females and 28 units or an average daily intake of greater than 4 units for males. Participation in a clinical trial with a new molecule entity within 3 months of the start of the study. Volunteers who have a clinical history of hepatitis B or C, or HIV infection. Donation or loss of 450 ml or more blood within the previous 12 weeks Clinically significant abnormality in clinical laboratory tests at screening as determined by the Principal Investigator Volunteers who in the opinion of the Principal Investigator are at risk of noncompliance or not completing the study procedures and schedule Any infirmity, disability, or geographic location, which, in the opinion of the Principal Investigator, would limit compliance with the protocol.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: To investigate the effects of IMD-1041 on NF-?B inhibition ex vivo.;Primary end point(s): Determination of safety, efficacy and potential therapeutic benefit of IKKB inhibition in man by oral dosing of IMD-1041.;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).