A Phase 1 Study in Healthy Chinese 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
- 30
- 试验地点
- 1
- 主要终点
- Apparent Clearance (CL/F) for Subcutaneous (SC) dosing
研究概览
简要总结
The objective of this study to assess the pharmacokinetics, safety, tolerability and immunogenicity following a single subcutaneous (SC) or intravenous (IV) dose of risankizumab in healthy Chinese 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
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body Mass Index (BMI) is >= 19.0 to <= 26.0 kg/m2 after rounding to the nearest tenth. BMI is calculated as weight in kg divided by the square of height measured in meters.
排除标准
- •Previous exposure to any anti-IL-12/23 or anti-IL-23 treatment.
研究组 & 干预措施
Dose A of Risankizumab for Subcutaneous (SC) Injection
Participants will receive SC injections of risankizumab at dose A and then followed for 140 days.
干预措施: Risankizumab (Drug)
Dose B of Risankizumab for Subcutaneous (SC) Injection
Participants will receive SC injections of risankizumab at dose B and then followed for 140 days.
干预措施: Risankizumab (Drug)
Dose C of Risankizumab for Intravenous (IV) Infusion
Participants will receive IV infusion of risankizumab at dose C and then followed for 140 days.
干预措施: Risankizumab (Drug)
结局指标
主要结局
Apparent Clearance (CL/F) for Subcutaneous (SC) dosing
时间窗: Up to Approximately 140 Days
CL/F for SC dosing.
Terminal Phase Elimination Half-life (t1/2)
时间窗: Up to Approximately 140 Days
Terminal phase elimination half-life.
Clearance (CL) for Intravenous (IV) Dosing
时间窗: Up to Approximately 140 Days
CL for IV dosing.
Time to Cmax (Tmax)
时间窗: Up to Approximately 140 Days
Time to Cmax.
Number of Participants with Adverse Events (AE)
时间窗: Up to Approximately 140 Days
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Maximum Observed Concentration (Cmax)
时间窗: Up to Approximately 140 Days
Maximum observed concentration.
Terminal Phase Elimination Rate Constant (β)
时间窗: Up to Approximately 140 Days
Terminal phase elimination rate constant.
Area Under the Concentration-Time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUCt)
时间窗: Up to Approximately 140 Days
AUC from time 0 to time of the last measurable concentration (AUCt).
AUC from Time 0 to Infinity (AUCinf)
时间窗: Up to Approximately 140 Days
AUC from time 0 to infinity (AUCinf).
Number of Anti-drug antibody (ADA) Titers
时间窗: Up to Approximately 140 Days
ADA titers will be tabulated for each participant at the respective study visits.
次要结局
未报告次要终点