Status:
COMPLETED
Immunological Effects From Intranasal Chitin Micro-Particles
Lead Sponsor:
University of Aarhus
Collaborating Sponsors:
CMP Therapeutics Ltd
Conditions:
Healthy
Eligibility:
All Genders
18-30 years
Phase:
NA
Brief Summary
The purpose of the study is: * To investigate whether chitin can effect healthy adults, the nasal mucosa in a direction that will enhance the immune response to infection * To investigate whether chi...
Detailed Description
STUDY SYNOPSIS Objectives Primary •To assess the effects of intranasal dosing of chitin micro-particles on nasal mucosa responses with respect to the concentration of cytokines (TNF-alfa, IFN-gamma,...
Eligibility Criteria
Inclusion
- • healthy non-smoking male or female volunteers between 18 and 30 years of age, inclusive (at screening).
- Subjects:
- asymptomatic at screening as characterized by normal appearing nasal mucosa with no active allergic rhinitis.
- be free from clinically significant cardiac, pulmonary, gastrointestinal, hepatic, neurological and psychiatric disease as determined by medical history, physical examination and screening investigations.
- with no clinically-significant deviation outside the normal ranges for blood pressure and pulse measurements.
- capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- be available to complete the study.
- satisfy a medical examiner about their fitness to participate in the study.
- provide oral and written informed consent to participate in the study.
Exclusion
- Subjects with:
- atopy
- perennial rhinitis.
- upper respiratory tract infection within 2 weeks of the first dose of study medication.
- medical conditions likely to affect the outcome of the study in the opinion of the investigator.
- nasal conditions likely to affect the outcome of the study in the opinion of the investigator, i.e. nasal septal perforations, nasal polyps, sinus disease, chronic nasal obstruction, or other nasal diseases.
- presence of any respiratory disease other than a history of mild stable asthma not requiring treatment and associated with normal lung function (defined as ≥ 80% predicted for height and age, "Danish Society of Lung Physicians 1986").
- a history of immunotherapy in the past 3 years or currently on an immunotherapy treatment course including inhaled or local corticosteroids in the past 28 days.
- any infirmity, disability, or geographic location which, in the opinion of the chief investigator, would limit compliance with the protocol.
- infection of the upper airways/lower airways, sinus, or ear, including viral infections in the 14 days prior to screening and at the start of/or during the treatment period.
- subjects with inability to tolerate lavage correctly with a preliminary nasal lavage at screening.
- participation in a study with a new molecular entity during the previous four months or any other trial during the previous three months.
- Subjects who/with:
- regularly, or on average, drink more than four units of alcohol per day.
- are in receipt of prescribed or over the counter medication (including herbal remedies and dietary supplements) within 14 days of the first dose of test article and for the duration of the trial (with the exception of paracetamol up to 2g daily). In particular, all antihistamines, chromoglycate and steroids are prohibited during this period.
- inability to communicate well with the investigator (i.e., language problem, poor mental development or impaired cerebral function).
- have donated 450 mL or more blood within the previous 12 weeks.
- clinical features suspicious of tuberculosis - weight loss, haemoptysis pyrexia, purulent sputum, previous abnormal chest X-ray will be excluded from the study.
- clinical evidence of autoimmune disease.
- with allergy to seafood or any of the excipients in the study drug formulation.
Key Trial Info
Start Date :
April 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT01508039
Start Date
April 1 2011
End Date
July 1 2011
Last Update
January 26 2012
Active Locations (1)
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1
Aarhus University, School of Public Health, Dept. of Environmental & Occupational Medicine
Aarhus C, Denmark, 8000