An Open, Non-controlled, Non-randomised, Parallel-group Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Doses of AZD 8848 Administered Intranasally to Male and Female Butyrylcholinesterase Deficient Subjects and to Sex and Age Matched Controls
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Safety and tolerability will be assessed by a panel of measurements including adverse events (AEs), vital signs, ECG, laboratory variables, physical examination, and clinical inspection of the nose
研究概览
简要总结
The purpose of this study is to investigate the safety and tolerability of AZD8848 in Butyrylcholinesterase deficient subjects in comparison with sex and age matched control subjects.
详细描述
An Open, Non-controlled, Non-randomised, Parallel-group Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Doses of AZD 8848 Administered Intranasally to Male and Female Butyrylcholinesterase deficient Subjects and to Sex and Age matched Controls
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BChE deficient subjects: The half-live of AZD8848 in plasma should be more than 20 minutes in an in vitro screening test
- •Matched control subject: The half-live of AZD8848 in plasma should be less than 2 minutes in an in vitro screening test
排除标准
- •Any clinically relevant abnormal findings in physical examination, laboratory assessments, vital signs or ECG
- •Present or medical history of cardiovascular disease which, in the opinion of the investigator, may either put subject at risk because of participation in the study or influence the result of the study or the subject's ability to participate in the study
- •Family history of autoimmune disease
研究组 & 干预措施
1
AZD8848 given to BChE deficient subjects and age & gender matched control subjects
干预措施: AZD8848 (Drug)
结局指标
主要结局
Safety and tolerability will be assessed by a panel of measurements including adverse events (AEs), vital signs, ECG, laboratory variables, physical examination, and clinical inspection of the nose
时间窗: Repeated assessments during Day 2.
次要结局
- Pharmacokinetics (concentration of AZD8848 and metabolite in plasma and urine)(Prior to administration of the IP (Day 0) and repeated assessments during the first 48h.)
- Pharmacodynamics (IL-1Ra in plasma)(Prior to administration of the IP (Day 0) and repeated assessments during the first 48h.)