A Phase 1 Study in Healthy Subjects to Evaluate the Bioavailability of Risankizumab 150mg/mL Formulation in the 180 mg Prefilled Syringe Relative to 90mg/mL Formulation in the 90 mg Prefilled Syringe
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 198
- 试验地点
- 5
- 主要终点
- The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC∞)
研究概览
简要总结
This study will assess how safe risankizumab is and how risankizumab moves through the body of adult healthy participants. Adverse Events will be assessed.
Risankizumab is an investigational drug being developed for the treatment of Crohn's Disease. Participants are randomly assigned to one of the 2 treatment groups. Approximately 198 adult healthy volunteers will be enrolled in at least 4 sites across the world.
All participants will receive risankizumab as subcutaneous injections in one of the 2 different formulations.
There may be higher burden for participants in this trial. Participants will be confined for 10 days and followed up for 140 days. Adverse Events and blood tests will be collected.
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 weight greater than 40 kg and less than 100 kg at screening and upon initial confinement.
排除标准
- •Previous exposure to any anti-interleukin-12/23 or anti-interleukin-23 treatment.
- •Intention to perform strenuous exercise to which the participant is unaccustomed within one week prior to administration of study drug or during the study.
研究组 & 干预措施
Risankizumab Dose A
Participants will receive subcutaneous dose of risankizumab dose A.
干预措施: Risankizumab Dose A (Drug)
Risankizumab Dose B
Participants will receive subcutaneous dose of risankizumab dose B.
干预措施: Risankizumab Dose B (Drug)
结局指标
主要结局
The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC∞)
时间窗: Approximately up to 113 days
The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC∞)
Maximum Observed Plasma Concentration (Cmax)
时间窗: Approximately up to 113 days
Maximum Observed Plasma Concentration (Cmax)
Number of Participants with Adverse Events
时间窗: Approximately up to 140 days
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.
Time to Maximum Observed Plasma Concentration (Tmax)
时间窗: Approximately up to 113 days
Time to Maximum Observed Plasma Concentration (Tmax)
Apparent Terminal Phase Elimination Rate Constant (β)
时间窗: Approximately up to 113 days
Apparent Terminal Phase Elimination Rate Constant (β)
The Terminal Phase Elimination Half-Life (t1/2)
时间窗: Approximately up to 113 days
The Terminal Phase Elimination Half-Life (t1/2)
The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUCt)
时间窗: Approximately up to 113 days
The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUCt)
次要结局
未报告次要终点