NCT02157714已完成1 期
A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of PRX002 Administered By Intravenous Infusion in Patients With Parkinson'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
- 入组人数
- 64
- 试验地点
- 8
- 主要终点
- Determination of pharmacokinetics parameters
研究概览
简要总结
This multiple ascending dose study is to determine safety, tolerability, pharmacokinetics and immunogenicity of PRX002 in approximately 60 patients with Parkinson's disease.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Idiopathic Parkinson's disease, Hoehn and Yahr 1-3
- •Body weight range of ≥ 45kg/99 lbs to ≤ 110 kg/242 lbs
- •Female subjects must be surgically sterile or post-menopausal or if of child-bearing potential must use contraception
- •Male subjects and their partners of childbearing potential must use contraception
排除标准
- •Significant cardiac history
- •Abnormal MRI
- •Significant laboratory abnormalities
研究组 & 干预措施
PRX002
Experimental
PRX002
干预措施: PRX002 (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Determination of pharmacokinetics parameters
时间窗: up to 6 months
minimum observed concentration (Cmin)
Safety and tolerability as determined by number of subjects with adverse events
时间窗: up to 6 months
次要结局
- Immunogenicity as determined by measurement of anti-PRX002 antibodies(up to 3 months)
研究者
研究点 (8)
Loading locations...
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