A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Effect on Biomarkers of AZD3293 in Healthy Japanese Male and Non-Fertile Female Volunteers Including Elderly
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Safety - Adverse Events
研究概览
简要总结
This study consists of two parts, ie, single dose part with young healthy subjects (Part 1) and single and multiple dose part with elderly healthy subjects (Part 2), to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD3293 following single and multiple ascending dose administration to healthy subjects.
详细描述
This is a Phase I, randomised, double-blind, placebo-controlled, single centre study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD3293 following single and multiple ascending dose administration to healthy subjects. This study consists of two parts, ie, single dose part with young healthy subjects (Part 1) and single and multiple dose part with elderly healthy subjects (Part 2). The study design allows a gradual escalation of dosage levels between sequential cohorts with safety monitoring to ensure the safety of the healthy subjects.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Japanese elderly and young males and females (of non-childbearing potential)
- •Body mass index (BMI) between 17 and 27 kg/m2 and weigh at least 40 kg and no more than 100 kg
排除标准
- •Psychiatric disease/condition, GI, renal, hepatic, cardiovascular, psychiatric, or retinal diseases or disorders
- •Use of antipsychotic drugs , or chronic use of antidepressant or anxiolytic drugs.
- •Frequent use (more than 2 days per week during the last 12 weeks) of tobacco or other nicotine products.
- •Neurological disease, including seizures, recent memory impairment, or clinically significant head injury.
研究组 & 干预措施
AZD3293
AZD3293 will be administered as single dose of an oral solution in Part 1 and single and multiple doses of an oral solution in Part 2. The ascending doses are planned to be 15, 50 and 150 mg for young subjects in Part 1 and 15 and 50 mg for elderly subjects in Part 2. Before proceeding to next dose level, safety, tolerability and pharmacokinetic data from the previous cohort(s) will be evaluated by a Safety Review Committee. Part 2 will start after confirming safety and tolerability in Part 1.
干预措施: AZD3293 (Drug)
Placebo
Placebo given (2 subjects in each cohort)
干预措施: Placebo (Drug)
结局指标
主要结局
Safety - Adverse Events
时间窗: Day of first dose to follow up
Safety - Number of subjects reporting any adverse events during the study
次要结局
- PK Cmax - Overall Study(0, 0.5,1,2,3,4,8,12,24,48 hr single dose, multiple dose does not include 48 hr)
- PK AUC - Overall Study (SAD & MAD Parts)(0,0.5,1,2,3,4,8,12,24,48 hr single dose, multiple dose does not include 48 hr)
- Biomarker(Pre dose vs Day 14)