A Phase 1 Pharmacokinetic Study in Healthy Subjects to Evaluate the Bioavailability of Risankizumab Following Subcutaneous Administration With Prefilled Pen Relative to Prefilled Syringe
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- Maximum Observed Plasma Concentration (Cmax) of Risankizumab
研究概览
简要总结
This study will assess the pharmacokinetics, relative bioavailability, immunogenicity, safety, and tolerability of risankizumab following subcutaneous (SC) administration with a prefilled pen or a prefilled syringe in healthy adult 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 60 Years（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 participant 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 Arm A
Participants will receive a single Subcutaneous (SC) injection of risankizumab Dose A administered via Prefilled Syringe (PFS) at Day 1
干预措施: Risankizumab (Drug)
Risankizumab Arm B
Participants will receive a single Subcutaneous (SC) injection of risankizumab Dose B administered via Prefilled Pen (PFP) at Day 1
干预措施: Risankizumab (Drug)
结局指标
主要结局
Maximum Observed Plasma Concentration (Cmax) of Risankizumab
时间窗: Up to approximately 141 days
Maximum observed plasma concentration (Cmax) of Risankizumab
Time to Cmax (Tmax) of Risankizumab
时间窗: Up to approximately 141 days
Tmax of Risankizumab
Apparent Terminal Phase Elimination Rate Constant (β) of Risankizumab
时间窗: Up to approximately 141 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 141 days
Terminal phase elimination half-life (t1/2) 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 141 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 141 days
AUCinf of Risankizumab
Number of Participants Experiencing Adverse Events
时间窗: Up to approximately 141 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