NCT01485302已完成1 期
A Multi-center, Parallel-group, Double-blind, Placebo-controlled Single and Multiple Dose Escalation Study to Assess the Safety and Tolerability and the Pharmacokinetic Properties of SAR228810 Given as IV Infusion or as SC Injection in Patients With Mild to Moderate Alzheimer's Disease.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 48
- 试验地点
- 8
- 主要终点
- number of patients with adverse events
研究概览
简要总结
Primary Objective:
- To assess the safety and tolerability of escalating single and multiple doses of SAR228810 in patients with Alzheimer's disease (AD)
Secondary Objective:
- To evaluate the pharmacokinetic properties of SAR228810 after escalating single and multiple doses of SAR228810 in AD patients
详细描述
14.5 to 22 months
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Cohort 1
Experimental
Dose 1 IV infusion
干预措施: SAR228810 (Drug)
Cohort 2
Experimental
Dose 2 IV infusion
干预措施: SAR228810 (Drug)
Cohort 3
Experimental
Dose 3 IV infusion
干预措施: SAR228810 (Drug)
Cohort 4
Experimental
Dose 4 IV infusion
干预措施: SAR228810 (Drug)
Cohort 5
Experimental
Dose 1 SC injection
干预措施: SAR228810 (Drug)
Cohort 6
Experimental
Dose 2 SC injection
干预措施: SAR228810 (Drug)
结局指标
主要结局
number of patients with adverse events
时间窗: 10 months
次要结局
- Cmax(1 to 112 days after dosing)
- t1/2z(1 to 112 days after dosing)
- brain magnetic resonance imaging(10 months)
- hematology, biochemistry, coagulation(10 months)
- vital signs, ECG(10 months)
- AUC(1 to 112 days after dosing)
研究者
研究点 (8)
Loading locations...
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