A Phase I, Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD1446 in Male and Non-fertile Female, Young and Elderly Healthy Volunteers, After Oral Multiple Ascending Doses
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Part A: to assess the safety and tolerability of AZD1446 following multiple ascending doses of an orally administered solution of AZD1446 in male and non-fertile female, young and elderly Healthy Volunteers,
研究概览
简要总结
This study is designed to evaluate the safety, tolerability and PK of AZD1446 in Subjects when given as multiple dose administration for either 7 Days (Day 1 single dose, Day 2-6 multiple doses) in Part A and optionally at fractionated doses for 1 Day in Part B.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or non-fertile female, young or elderly Subjects, aged ≥18 to ≤50 or ≥65 to ≤80
- •Body mass index (BMI) between 19 and 30 kg/m2
- •Clinically normal findings on physical examination
排除标准
- •History of any clinically significant disease or disorder
- •History of severe allergy/hypersensitivity reactions
研究组 & 干预措施
1
Part A single and multiple dose and part B fractionated dose
干预措施: AZD1446 (Drug)
2
干预措施: Placebo (Drug)
结局指标
主要结局
Part A: to assess the safety and tolerability of AZD1446 following multiple ascending doses of an orally administered solution of AZD1446 in male and non-fertile female, young and elderly Healthy Volunteers,
时间窗: during the whole study period, ca 50 days
Part B: to assess the safety and tolerability of AZD1446 following administration of an oral solution of AZD1446 as fractionated doses during one day in male and non-fertile female, young and elderly Healthy Volunteers.
时间窗: during the whole study period, ca 43 days
次要结局
- Part B: To mimic an extended release dosing regimen and determine the fractionated dosing PK of AZD1446 in male and non-fertile Healthy Volunteers.(PK sampling taken at defined timepoints during residential period, 10 days for Part A and 4 days for Part B)
- Part A: To determine the single and multiple dose PK of AZD1446 in male and non-fertile female Healthy Volunteers.(PK sampling taken at defined timepoints during residential period, 10 days for Part A and 4 days for Part B)