A Randomized Open-Label Single Dose Study to Evaluate the Effect of Rate and Volume of Administration on the Bioavailability of Risankizumab Following Subcutaneous (SC) Dosing in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Number of Participants with Adverse Events
研究概览
简要总结
The objective of this study is to evaluate the bioavailability, safety and tolerability of risankizumab following subcutaneous injections in healthy male 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 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Body weight less than 100.00 kg inclusive at Screening and Check-In Day.
- •Body Mass Index (BMI) is ≥ 18.0 to ≤ 29.9 kg/m2 after rounded to the tenths decimal, at Screening and upon confinement.
排除标准
- •Previous exposure to any anti-IL-12/23 or anti-IL-23 treatment.
- •History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
研究组 & 干预措施
Risankizumab Dose A
Participants will receive 3 Subcutaneous (SC) injections of risankizumab Dose A administered via prepared syringe at Day 1 and followed for 140 days.
干预措施: risankizumab (Drug)
Risankizumab Dose B
Participants will receive 1 SC injection of risankizumab Dose B administered via syringe pump at Day 1 and followed for 140 days.
干预措施: risankizumab (Drug)
Risankizumab Dose C
Participants will receive 1 SC injection of risankizumab Dose C administered via syringe pump at Day 1 and followed for 140 days.
干预措施: risankizumab (Drug)
Risankizumab Dose D
Participants will receive 1 SC injection of risankizumab Dose D administered via prepared syringe at Day 1 and followed for 140 days.
干预措施: risankizumab (Drug)
结局指标
主要结局
Number of Participants with Adverse Events
时间窗: Up to 140 Days
An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of study drug.
Maximum Observed Plasma Concentration (Cmax)
时间窗: Up to 140 Days
Maximum Observed Plasma Concentration
Time to maximum observed plasma concentration (Tmax)
时间窗: Up to 140 Days
Time to maximum observed plasma concentration
Terminal phase elimination rate constant (β)
时间窗: Up to 140 Days
Terminal phase elimination rate constant
AUC from time 0 to infinity (AUCinf)
时间窗: Up to 140 Days
AUC from time 0 to infinity
Terminal phase elimination half-life (t1/2).
时间窗: Up to 140 Days
Terminal phase elimination half-life
Area under the plasma concentration-time curve (AUC) from time 0 to the time of last measurable concentration (AUCt)
时间窗: Up to 140 Days
AUC from time 0 to the time of last measurable concentration
Number of Anti-drug antibody (ADA) Titers
时间窗: Up to 140 Days
Incidence of anti-drug antibodies
次要结局
未报告次要终点