A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of PRX003 Administered by Intravenous Infusion in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Safety and tolerability as determined by number of subjects with adverse events
研究概览
简要总结
This single ascending dose study is to determine safety, tolerability, pharmacokinetics and immunogenicity of PRX003 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 50 Years（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 45 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 TB, hepatitis B, hepatitis C or HIV infection
研究组 & 干预措施
PRX003
干预措施: PRX003 (Drug)
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Safety and tolerability as determined by number of subjects with adverse events
时间窗: Up to 3 months
Determination of pharmacokinetics parameters-(Cmax)
时间窗: Up to 3 months
maximum concentration (Cmax)
Determination of pharmacokinetics parameters-(AUClast)
时间窗: Up to 3 months
area under the concentration-time curve from time zero to the last quantifiable concentration time-point (AUClast)
Determination of pharmacokinetics parameters-(AUCinf)
时间窗: Up to 3 months
area under the concentration-time curve from time zero extrapolated to infinity (AUCinf)
Determination of pharmacokinetics parameters-elimination rate constant
时间窗: Up to 3 months
elimination rate constant
Determination of pharmacokinetics parameters-(t½)
时间窗: Up to 3 months
terminal elimination half life (t½)
Determination of pharmacokinetics parameters-(CL)
时间窗: Up to 3 months
clearance (CL)
Determination of pharmacokinetics parameters-(Vd)
时间窗: Up to 3 months
apparent volume of distribution (Vd)
次要结局
- Immunogenicity as determined by measurement of anti-PRX003 antibodies(Up to 3 months)