A Phase I, Open-label, Single-Arm, Multiple-Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Anifrolumab in Chinese Participants With Systemic Lupus Erythematosus (SLE)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 15
- 试验地点
- 3
- 主要终点
- Time to maximum observed plasma concentration (Tmax) of anifrolumab.
研究概览
简要总结
To assess the pharmacokinetic parameters of anifrolumab in Chinese participants with active systemic lupus erythematosus(SLE).
详细描述
This is a Phase I, open-label, single-arm, multiple-dose study to evaluate the pharmacokinetics (PK), pharmacodynamics(PD), safety and tolerability profile of intravenously administered anifrolumab in Chinese participants with active SLE despite receiving standard of care (SOC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Time to maximum observed plasma concentration (Tmax) of anifrolumab.
时间窗: Day 1 to Day 141
To characterise the pharmacokinetic (PK) profile of anifrolumab via intravenous (IV) infusion.
Maximum observed plasma concentration (Cmax) of anifrolumab.
时间窗: Day 1 to Day 141
To characterise the pharmacokinetic (PK) profile of anifrolumab via intravenous (IV) infusion.
The volume of plasma cleared of drug per unit time (CL) of anifrolumab.
时间窗: Day 1 to Day 141
To characterise the pharmacokinetic (PK) profile of anifrolumab via intravenous (IV) infusion.
Pre-dose trough concentration (Ctrough) of anifrolumab.
时间窗: Day 1 to Day 141
To characterise the pharmacokinetic (PK) profile of anifrolumab via intravenous (IV) infusion.
Area under plasma concentration-time curve over dosing interval (AUC[tau]) of anifrolumab.
时间窗: Day 1 to Day 141
To characterise the pharmacokinetic (PK) profile of anifrolumab via intravenous (IV) infusion.
次要结局
- Incidence of adverse events(From Screening, Day 1 to Day 141)
- 21-gene Type I interferon PD signature(Screening, Day 29, 85, 113, 141)
- Anti-drug antibodies (ADA)(Day 1, 85, 113, 141)
- Incidence of abnormal vital signs(From Screening, Day 1 to Day 141)
- Incidence of abnormal laboratory parameters(Day 29, 57, 85, 113, 141)