A Study to Evaluate the Pharmacokinetics of Ustekinumab Following a Single Subcutaneous Administration of 45 mg or 90 mg to Healthy, Chinese, Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 主要终点
- Determine what the body does to ustekinumab (pharmacokinetics) in Chinese Male participants.
研究概览
简要总结
A study of the pharmacokinetics of ustekinumab in Chinese male subjects.
详细描述
This is a randomized (study medication assigned by chance), open-label (both the physician and subject know the assigned study medication) study to assess the safety, tolerability, immune response, pharmacokinetics (what the body does to the drug), of ustekinumab (Stelara). The study population will consist of 24 healthy male participants in China. Participants will receive a single dose of either 45mg or 90 mg ustekinumab. Participants will be in the study for up to 16 weeks. Safety assessments will be performed throughout the study and include obtaining and evaluating laboratory tests, vital signs (e.g., blood pressure), and the occurrence and severity of adverse events. A single dose of 45 mg or 90 mg ustekinumab.
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
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Have no clinically relevant abnormalities
- •Non smoker
排除标准
- •Have or had a history of clinically significant, severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease
- •Have any underlying physical or psychological medical condition
- •Be unable or unwilling to undergo multiple venipunctures because of poor tolerability or lack of easy access to veins
研究组 & 干预措施
001
ustekinumab Single dose of 45 mg subcutaneous injection
干预措施: ustekinumab (Drug)
002
ustekinumab Single dose of 90 mg subcutaneous injection
干预措施: ustekinumab (Drug)
结局指标
主要结局
Determine what the body does to ustekinumab (pharmacokinetics) in Chinese Male participants.
时间窗: Week 16
次要结局
- Immune response (immunogenicity) of ustekinumab(Week 16)
- Safety and tolerability of ustekinumab by evaluating laboratory tests, vital signs (e.g., blood pressure), and the occurrence and severity of adverse events(Week 16)