A Phase 1 Study in Healthy Subjects to Assess Pharmacokinetics Following Intravenous and Subcutaneous Administration of Risankizumab
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Number of Participants with Adverse Events (AEs)
研究概览
简要总结
The purpose of this study is to compare how the drug moves through the body following risankizumab subcutaneous (SC) and risankizumab intravenous (IV) doses.
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 weight between 40 kg and 100 kg inclusive at screening and upon initial confinement.
- •BMI is ≥ 18.0 to ≤ 32.0 kg/m2 after rounding to the tenths decimal at Screening. BMI is calculated as weight in kg divided by the square of height measured in meters.
- •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
- •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 subject is unaccustomed within one week prior to administration of first dose of study treatment or during the study.
研究组 & 干预措施
Risankizumab Dose A
Participants will receive Dose A of risankizumab via intravenous (IV) infusion.
干预措施: Risankizumab (Drug)
Risankizumab Dose B
Participants will receive Dose B of risankizumab via subcutaneous (SC) injection.
干预措施: Risankizumab (Drug)
结局指标
主要结局
Number of Participants with Adverse Events (AEs)
时间窗: Up to Approximately 155 Days
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Maximum Observed Serum Concentration (Cmax) of Risankizumab
时间窗: Up to Approximately 155 Days
Cmax of Risankizumab.
Time to Cmax (Tmax) of Risankizumab
时间窗: Up to Approximately 155 Days
Tmax of Risankizumab.
Area Under the Serum Concentration-Time Curve (AUC) of Risankizumab
时间窗: Up to Approximately 155 Days
AUCt of Risankizumab.
次要结局
未报告次要终点