A Study in Healthy Japanese and Caucasian Subjects to Assess the Pharmacokinetics, Safety and Tolerability After a Single Dose of Risankizumab
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Time to Cmax (Cmax) of Risankizumab
研究概览
简要总结
The main objective of this study is to assess the pharmacokinetics, safety, tolerability and immunogenicity following a single intravenous (IV) infusion of risankizumab in healthy Japanese and Caucasian participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Must be first or second generation Japanese of full parentage residing outside of Japan for less than 10 years. First generation participants will have been born to two parents and four grandparents also born in Japan of full Japanese descent. Second generation participants born outside of Japan must have two parents and four grandparents born in Japan of full Japanese descent. All participants must maintain a typical Japanese lifestyle, including consuming a typical Japanese diet or participants must be Caucasian and not of Hispanic ethnicity.
- •Body Mass Index (BMI) is >= 18.5 and <= 29.9 kg/m2 (after rounding to the tenths decimal) at Screening. BMI is calculated as weight in kilograms (kg) divided by the square of height measured in meters (m).
排除标准
- •Previous exposure to any anti-IL-12/23 or anti-IL-23 treatment.
- •Any findings in the medical examination that are deviating from normal and judged as clinically relevant by the investigator.
- •Any laboratory value outside the reference range that the investigator considers to be of clinical relevance.
- •Any evidence of a concomitant disease judged as clinically relevant by the investigator.
研究组 & 干预措施
Caucasian Participants Receiving Placebo
Participants will receive single dose of placebo.
干预措施: Placebo (Drug)
Japanese Participants Receiving Risankizumab
Participants will receive single dose of risankizumab.
干预措施: Risankizumab (Drug)
Japanese Participants Receiving Placebo
Participants will receive single dose of placebo.
干预措施: Placebo (Drug)
Caucasian Participants Receiving Risankizumab
Participants will receive single dose of risankizumab.
干预措施: Risankizumab (Drug)
结局指标
主要结局
Time to Cmax (Cmax) of Risankizumab
时间窗: Up to approximately 137 days
Tmax of Risankizumab.
Apparent Terminal Phase Elimination Rate Constant (β) of Risankizumab
时间窗: Up to approximately 137 days
Apparent terminal phase elimination rate constant (β) of Risankizumab.
Terminal Phase Elimination Half-life (t1/2) of Risankizumab
时间窗: Up to approximately 137 days
Terminal phase elimination half-life (t1/2) of Risankizumab.
Maximum Observed Plasma Concentration (Cmax) of Risankizumab
时间窗: Up to approximately 137 days
Maximum observed plasma concentration (Cmax) of Risankizumab.
Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Last Measurable Concentration (AUCt) of Risankizumab
时间窗: Up to approximately 137 days
AUCt of Risankizumab.
Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Infinity (AUCinf) of Risankizumab
时间窗: Up to approximately 137 days
AUCinf of Risankizumab.
Number of Participants Experiencing Adverse Events
时间窗: Up to approximately 137 days
An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
次要结局
未报告次要终点