Immunological Effects From Intranasal Chitin Micro-Particles

NCT01508039 | Completed DMC

• 1 other identifier: CMP-001-008
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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 chitin influence of the nasal mucosa is well tolerated, and that there is no inflammation, as it seen with exposure to endotoxin.

Conditions

Healthy

Keywords

Intranasal; Chitin Micro-particles; Immunological Effects; Nasal mucosa; Cytokines; Immunological Effects from Intranasal Chitin Micro-Particles

Outcome Measures

Primary Outcomes (1)

• Changes in levels of cytokines in nasal lavage fluid compared with dosing with placebo.

  Change in levels of cytokines (TNF-alfa, IFN-gamma, IL-1b, IL-4 IL5, IL, 6, IL-8, IL-10 and IL-13) in nasal lavage fluid compared to dosing with placebo.

  Period 1, day 0. Period 2, day 14

Secondary Outcomes (3)

• Changes in levels of cytokines in nasal lavage fluid compared with dosing with active control.

  Day0, day 14,day 28.

• Change from baseline.

  Day 0, day 14, day 28

• Safety check.

  Day0, day14, day 28.

Study Arms (1)

Treatment with chitin micro-particles

EXPERIMENTAL

The study will involve 14-healthy subjects confirming to the inclusion criteria randomised to the treatments.

Other: Chitin Micro Particle

Interventions

Chitin Micro Particle OTHER

The total spray volume for each application is 0.4 ml equivalent to a total single-dose for chitin of 2 mg (0.5 mg per 0.1 ml spray). A total single-dose for LPS, of 2 mg of endotoxin from Enterobacter agglomerans (0.5 mg per 0.1 ml spray)

Also known as: Chitin micro-particle

Treatment with chitin micro-particles

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Aarhus: lead
• CMP Therapeutics Ltd: collaborator

Study Sites (1)

Aarhus University, School of Public Health, Dept. of Environmental & Occupational Medicine

Aarhus C, 8000, Denmark

Location

Study Officials

• Torben Sigsgaard, Professor

  Aarhus University, School of Public Health, Dept of Environmental & Occupational Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2011
• First Posted: January 11, 2012
• Study Start: April 1, 2011
• Primary Completion: June 1, 2011
• Study Completion: July 1, 2011
• Last Updated: January 26, 2012

Record last verified: 2012-01

Locations

DK (1)