A Phase 1, Randomized, Double-blind, Placebo-controlled, Single-center, Single-dose, Dose-escalating Study to Evaluate the Safety and Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of CDP6038 in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- The maximum drug concentration (Cmax) of CDP6038 in plasma given by intravenous (iv) infusion and subcutaneous (sc) injection in healthy male subjects.
研究概览
简要总结
To evaluate the safety, tolerability, blood levels and effects of CDP6038 administered by intravenous infusion (iv) and subcutaneous (sc) injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Body mass index between 19.0 and 28.0 kg/m² and body weight between ≥ 50 kg and ≤ 120 kg
排除标准
- •Previous trial participation or blood donation/loss within 3 months
- •Subject is not healthy (eg significant medical history, taking drug treatments, any psychological or emotional problems, or drug or alcohol abuse (current or historical)
- •Plans for or actual vaccination within 3 months
- •Previous drug treatments
- •Tobacco use or heavy caffeine consumption
- •Systolic blood pressure <90 or >145mmHg, diastolic blood pressure <40 or >90mmHg or heart rate <45 or >90 beats per minute
结局指标
主要结局
The maximum drug concentration (Cmax) of CDP6038 in plasma given by intravenous (iv) infusion and subcutaneous (sc) injection in healthy male subjects.
时间窗: Baseline to 14 weeks
The area under the plasma concentration/time curve from hour 0 to the time with the last quantifiable level of CDP6038 given by iv infusion and sc injection in healthy male subjects.
时间窗: Baseline to 14 weeks
The area under the plasma concentration/time curve extrapolated to infinity, of CDP6038 given by iv infusion and sc injection in healthy male subjects.
时间窗: Baseline to 14 weeks
The half life of CDP6038 in plasma given by iv infusion and sc injection in healthy male subjects.
时间窗: Baseline to 14 weeks
The apparent volume of distribution of CDP6038 given by iv infusion and sc injection in healthy male subjects.
时间窗: Baseline to 14 weeks
Total body clearance of CDP6038 in plasma given by iv infusion and sc injection in healthy male subjects.
时间窗: Baseline to 14 weeks
PK/PD relationship between systemic CDP6038 exposure and suppression of selected acute phase markers (such as C-reactive protein) following CDP6038 administration by iv infusion and sc injection in healthy male subjects.
时间窗: Baseline to 14 weeks
次要结局
- Anti-CDP6038 antibodies in plasma following iv infusion and sc injection of CDP6038 in healthy male subjects.(Baseline to 14 weeks)