NCT01508039已完成不适用
A Randomised, Double-blind,Single-dose,Placebo and Single-blind Active Controlled Cross-over Study in Healthy Volunteers to Access in Effects of Intranasal Chitin Micro-particles on the Release of Cytokines From Nasal Mucosa
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Changes in levels of cytokines in nasal lavage fluid compared with dosing with placebo.
研究概览
简要总结
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.
详细描述
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, IL-1b, IL-4 IL5, IL, 6, IL-8, IL-10 and IL-13) in nasal lavage fluid compared to dosing with placebo.
Secondary
- 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, IL-1b, IL-4 IL5, IL, 6, IL-8, IL-10 and IL-13) in nasal lavage fluid compared to dosing with active control.
- To assess the total eosinophil counts and cysteinyl leukotriene concentration in nasal lavage fluid at 4 and 8 hours post-dosing compared to pre-dosing.
- To assess the total nasal symptom scores at 4 and 8 hours post-dosing.
- To assess the safety and tolerability of chitin micro-particles dosed intranasally.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy non-smoking male or female volunteers between 18 and 30 years of age, inclusive (at screening).
- •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.
排除标准
- •Subjects with:
- •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.
结局指标
主要结局
Changes in levels of cytokines in nasal lavage fluid compared with dosing with placebo.
时间窗: Period 1, day 0. Period 2, day 14
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.
次要结局
- 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.)
研究者
研究点 (2)
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