ISRCTN46666382已完成不适用
The human nasal lipopolysaccharide (LPS) challenge model reflects inflammatory events in the lower airways, illustrated by CXCR2 inhibition of neutrophil recruitment: a placebo-controlled double-blind, cross-over study
AstraZeneca (Sweden)0 个研究点目标入组 18 人开始时间: 2011年2月17日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Provision of informed consent prior to any study specific procedures
- •2. Be willing and able to comply with study procedures
- •3. Healthy men or women aged 18 to 50 years (inclusive). Women must be of non-childbearing potential, that is women who are permanently sterilized (hysterectomy and/or bilateral oophorectomy or salpingectomy).
- •4. Have a body mass index (BMI) between 18 and 30 kg/m2 (inclusive) and minimum body weight of 50 kg
- •5. A blood neutrophil count above 2.2 x 10^9/L
- •6. Be non-smokers, or ex-smokers who have not smoked (or used any other nicotine products) in the 12 months preceding Visit 1 with a pack-year history of less than 10
排除标准
- •1. Any clinically relevant disease and/or abnormality (past or present), which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results of the study, or the subject's ability to participate in the study
- •2. A definite or suspected personal or family history of intolerance or hypersensitivity to drugs and/or their excipients, judged to be clinically relevant by the investigator
- •3. Surgery or significant trauma within 3 months of Visit 1
- •4. Symptoms, signs or laboratory findings suggestive of an ongoing infective illness, as judged by the investigator, at Visit 1
- •5. Current or recurrent atopic symptoms, ie, rhinitis, asthma or conjunctivitis of clinical relevance as judged by the investigator
- •6. Participation in any clinical study with an investigational drug or new formulation of a marketed drug in the 3 months prior to Visit 1, or participation in a methodology study 1 month prior to Visit 1 (Note: participation is identified as the completion of a treatment-related visit)
- •7. Donation of blood within 3 months and plasma within 14 days prior to Visit 1
- •8. Use of any medication (other than hormone replacement therapy [HRT]), including vaccinations or over-the-counter medication (e.g., herbal remedies, vitamins or nutritional supplements) within 2 weeks in relation to first administration of study drug (or longer if the medication has a half-life long enough to potentially expose the subject to any significant systemic exposure that may interfere with the objectives of the study or the safety of the subjects), as judged by the investigator. Occasional intake of paracetamol, maximum 1 g 4 times daily (qid), is allowed.
- •9. Past or present alcohol or drug abuse, as judged by the investigator, or positive drugs of abuse test
- •10. Positive results on screening tests for serum hepatitis B surface antigen, hepatitis C antibodies and/or human immunodeficiency virus (HIV)
- •11. A suspected/manifested infection according to World Health Organization (WHO) risk classification 2, 3 or 4
- •12. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
- •13. Previous randomisation into the present study
- •14. Subjects, who in the opinion of the investigator, should not participate in the study
- •15. Subjects being recently extensively exposed to passive smoking or environmental LPS (eg, swine farms) as judged by the investigator
- •16. Previous participation in another LPS study during the last 12 months
- •17. Suspicion of Gilbert's syndrome
- •18. Structural abnormalities of the nose or nasal disorder symptomatic enough to cause significant nasal obstruction, as judged by the investigator
研究者
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