DRKS00026925Enrolling By Invitation未知
Bio samples and bio markers for development of the biosensor toolkit within the REMEDIA project - 21-13 REMEDIA
Fraunhofer-Institut für Toxikologie und Experimentelle Medizin ITEM0 个研究点目标入组 11 人开始时间: 2021年10月20日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 11
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 50 Years（—）
- 性别
- All
入选标准
- •Able and willing to give written informed consent
- •- Study population: Healthy male and female subjects, aged 18 to 50 years (inclusive). Female subjects must not be pregnant or nursing. Women of child bearing potential must use a highly effective contraception method during the study
- •- Subjects must be able to produce adequate sputum (= 2× 105 total non-squamous cells)
- •- Body mass index between 18 and 32 kg/m2 (inclusively)
- •- Subject must be non-smoker with a history of less than 1 pack year and not having smoked in the past years
- •- Appropriate lung function with FEV1 = 80 % of predicted value
排除标准
- •- History of allergic rhinitis in the past 5 years
- •- Acute infection or any upper respiratory tract infection four weeks prior to informed consent visit
- •- Administration of corticosteroids via any route (e.g. intranasal, inhaled, oral) 4 weeks prior to informed consent visit
研究者
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