A Phase 1, Open-label Study to Assess PK Exposures Following Intravenous and Subcutaneous Administration of Risankizumab in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Area Under the Serum Concentration-Time Curve (AUC) of Risankizumab
研究概览
简要总结
The objective of this study is to compare pharmacokinetic exposures following intravenous and subcutaneous administration of Risankizumab.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body Mass Index (BMI) ≥ 18.0 to ≤ 32.0 kg/m^2 after rounding to the tenths decimal at the time of screening and upon initial confinement. BMI is calculated as weight in kg divided by the square of height measured in meters.
- •Body weight greater than 40 kg and less than 100 kg at screening and upon initial confinement.
- •A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead ECG
排除标准
- •Previous exposure to any anti-interleukin-12/23 or anti interleukin-23 treatment for at least one year prior to Screening.
- •Intention to perform strenuous exercise to which the particpant is unaccustomed within one week prior to administration of first dose of study drug and during the study.
研究组 & 干预措施
Risankizumab Dose A for Intravenous (IV) Infusion
Participants will receive IV infusion of risankizumab at dose A and then followed for 140 days.
干预措施: Risankizumab (Drug)
Risankizumab Dose B 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)
结局指标
主要结局
Area Under the Serum Concentration-Time Curve (AUC) of Risankizumab
时间窗: Up to approximately Week 4
AUCt of Risankizumab.
Number of Participants Experiencing Adverse Events
时间窗: Up to approximately 140 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.
Maximum Observed Serum Concentration (Cmax) of Risankizumab
时间窗: Up to approximately 140 days
Cmax of Risankizumab.
Time to Cmax (Tmax) of Risankizumab
时间窗: Up to approximately 140 days
Tmax of Risankizumab.
次要结局
未报告次要终点