A double blind, placebo controlled, parallel group study with an open label reference arm to assess the effects of intravenously administered AIN457 on ozone induced neutrophilia compared to placebo and oral corticosteroid in healthy volunteers

ovartis Pharma Services AG0 个研究点目标入组 24 人开始时间: 2008年11月4日最近更新: 2012年3月19日

研究概览

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•Healthy male and female subjects age 18 to 55 years of age. Female subjects of child bearing potential will be excluded.
•Able to produce sputum with normal sputum neutrophil levels at screening (<65% of non-epithelial cells) and are ozone responsive (=50% absolute increase in sputum neutrophils at 24h, visit 3)
•Screening FEV1 at least 80% of predicted.
•Negative latent tuberculosis blood test at screening
•Able to communicate well with the investigator, to understand and comply with the requirements of the study. Understand and sign the written informed consent.
•Subjects must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 to 35 kg/m2. See Appendix 3 of this protocol for BMI ranges.
•Other inclusion criteria are outlined in the protocol
•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) no
•F.1.3.1 Number of subjects for this age range

•Treatment with an immunosuppressive agent within the last six months.
•Presence or history of a major chronic inflammatory autoimmune disease like psoriasis, psoriatic arthritis, rheumatoid arthritis, spondyloarthropathy, inflammatory bowel disease or systemic lupus erythematesus (SLE).
•---Full inclusion / exclusion criteria are presented in the protocol---

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