NCT02095171已完成1 期
A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of PRX002 Administered by Intravenous Infusion in Healthy Subjects
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
- 40
- 主要终点
- Determination of pharmacokinetics parameters
研究概览
简要总结
This single ascending dose study is to determine safety, tolerability, pharmacokinetics and immunogenicity of PRX002 in approximately 40 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
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects
- •Body mass index (BMI) between 18-32 kg/m2 with a minimum weight of 46 kg
- •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
- •Positive test for drug of abuse
- •Past or current history of alcohol abuse
- •Positive for hepatitis B, hepatitis C or HIV infection
研究组 & 干预措施
PRX002
Experimental
干预措施: PRX002 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Other)
结局指标
主要结局
Determination of pharmacokinetics parameters
时间窗: up to 3 months
- apparent volume of distribution (Vd)
Safety and tolerability as determined by number of subjects with adverse events
时间窗: up to 3 months
次要结局
- Immunogenicity as determined by measurement of anti-PRX002 antibodies(up to 3 months)
研究者
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