A Randomised, Double-Blind, Placebo Controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MEDI1814 in Subjects With Mild to Moderate Alzheimer's Disease.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 77
- 试验地点
- 10
- 主要终点
- Tolerability as Measured by Participant Withdrawal for an Adverse Event
研究概览
简要总结
The purpose of this study is to assess the safety, drug levels and effects on the body of 1 or 3 injections of MEDI1814, in people with mild to moderate Alzhiemer's Disease or healthy elderly people.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 55 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female (non child bearing potential) subjects Mild-moderate Alzheimer's Disease
排除标准
- •History or evidence of significant autoimmune disease Presence of psychiatric disorder which would affect completion of the study Current serious or unstable clinically important illness
研究组 & 干预措施
MEDI1814 IV
Upto 10 cohorts of subjects are planned to be dosed by IV injection, with single and multiple ascending doses ranging from 25-1800mg.
干预措施: MEDI1814 for IV injection (Biological)
IV Placebo
Upto 10 cohorts of subjects are planned to be dosed by IV injection, with single and multiple ascending doses ranging from 25-1800mg.
干预措施: MEDI1814 for IV injection (Biological)
IV Placebo
Upto 10 cohorts of subjects are planned to be dosed by IV injection, with single and multiple ascending doses ranging from 25-1800mg.
干预措施: IV Placebo (Biological)
MEDI1814 Sub Cutaneous Injection
2 cohorts of subjects are planned to be dosed by sub cutaneous injection, one single ascending dose and one multiple ascending dose cohort
干预措施: MEDI1814 for Subcutaneous Injection (Biological)
Subcutaneous Placebo
2 cohorts of subjects are planned to be dosed by sub cutaneous injection, one single ascending dose and one multiple ascending dose cohort
干预措施: Placebo for Subcutaneous Injection (Biological)
结局指标
主要结局
Tolerability as Measured by Participant Withdrawal for an Adverse Event
时间窗: 4 months SAD; 7 months MAD
Tolerability measured by participant withdrawal for an adverse event from randomization through end of study
次要结局
- Mean Termination Half Life (t 1/2) of Medi1814(1 month)
- Maximum Plasma Concentration (Cmax) of Medi1814(1 month)
- Biomarkers: Amyloid-beta in Cerebral Spinal Fluid (Two Amyloid Bets Peptides of 40 and 42 Amino Acids Were Assessed)(Day 29 in SAD; Day 85 in MAD)
- Area Under the Concentration Time Curve (AUC) Time 0 to t (28 Days After 1st Dose SAD and MAD and After 3rd Dose in MAD, Day 57)(1 month)
- Biomarker: Total Amyloid-beta 1-42 in Plasma(Day 29 in SAD; Day 85 in MAD)
- Medi1814 Concentration in CSF Samples(SAD Day 29; MAD Day 85)
- Immunogenicity: Anti-drug Antibody Titer(4 months SAD (6 tests over 4 months; week 1, 2, 4, 8, 12, 16); 7 months MAD (7 monthly tests))