NCT00889460已完成1 期
Phase I Study to re-Investigate the Safety, Tolerability and Pharmacodynamic Effects of SLIT(Tablets) With Recombinant Bet v1 Given in Single Rising Doses and in Multi Dose Regimens to Subjects Sensitised to Birch Pollen
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Local tolerability
研究概览
简要总结
The purpose of this study is to determine the safety and tolerability of several doses of r Bet v1 administered as sub-lingual tablets in subjects sensitised to birch pollen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •written consent
- •Male or female subject from 18 to 60 years old and in general good health
- •For woman of child bearing potential:
- •Symptoms of birch pollen induced allergic rhinitis for at least the last 2 years.
- •Sensitisation to birch pollen as demonstrated with a positive SPT to birch pollen and specific IgE level (birch pollen and r Bet v1) >0.70 kU/L at screening.
- •FEV1 at least of 80% of predicted values at screening.
- •Subject accepting to comply fully with the protocol.
排除标准
- •Past or current disease which as judged by the Investigator, may affect the outcome of this study.
- •History of life-threatening asthma,
- •Asthma requiring daily treatment (whatever the pharmaceutical class).
- •Pregnant or lactating woman.
- •Subject being treated with inhaled steroids within 4 weeks prior to screening visit or within 12 weeks prior to screening visit.
- •Subject who previously received desensitisation treatment to birch pollen and/or other betulaceae (e.g., hazel tree, alder) or who plan to start desensitisation treatment during this study.
- •Symptoms during the treatment phase due to a sensitivity to a second allergen.
- •Subjects treated with ongoing immunotherapy with another allergen
结局指标
主要结局
Local tolerability
时间窗: Assessed every day over 2 weeks
Global safety
时间窗: Assessed every day over 2 weeks
次要结局
- Immunological markers (IgE and IgG4)(Between selection and follow-up visit (up to 18 weeks))
研究者
研究点 (2)
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