A Phase 1, Randomized, Double-blind, Placebo Controlled, Single-center, Single Dose Study to Evaluate the Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of CDP6038 Administered Subcutaneously to Healthy Japanese Males
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Maximum drug concentration (Cmax)
研究概览
简要总结
To evaluate the safety and tolerability of CDP6038 following single dose subcutaneous (sc) administration of CDP6038 to Japanese subjects.
To evaluate the Pharmacokinetics of CDP6038 following single dose sc administration of CDP6038 to Japanese subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy Japanese volunteers
排除标准
- •Subject has participated in any other clinical drug study (including a biologic product or a medical device) within 5 PK half-lives or 3 months (whichever is longer) prior to Screening, or the subject is currently participating in another clinical study.
- •Subject is not healthy (eg, taking any drug treatments, any psychological or emotional problems, a drug/alcohol abuse or a having a history of drug/alcohol abuse, having abnormal safety parameters)
结局指标
主要结局
Maximum drug concentration (Cmax)
时间窗: Multiple sampling from 0 to 113 days following single dose
Area under the plasma drug concentration versus time curve from hour 0 to the time with a last quantifiable level (AUC0-t)
时间窗: Multiple sampling from 0 to 113 days following single dose
Area under the plasma drug concentration versus time curve extrapolated to infinity (AUC)
时间窗: Multiple sampling from 0 to 113 days following single dose
Apparent volume of distribution (Vz/F)
时间窗: Multiple sampling from 0 to 113 days following single dose
Apparent total body clearance (CL/F)
时间窗: Multiple sampling from 0 to 113 days following single dose
Terminal elimination half-life (T½)
时间窗: Multiple sampling from 0 to 113 days following single dose
次要结局
- PK/PD relationship between systemic CDP6038 exposure and suppression of selected acute phase markers (such as C-reactive protein), following single subcutaneous doses of CDP6038 in Japanese subjects(Multiple sampling from 0 to 15 weeks following single dose)
- Immunogenicity of single subcutaneous doses of CDP6038 in Japanese subjects(Multiple sampling from 0 to 15 weeks following single dose)