A Randomized, Double-blind, Single-center, Cross-over Study to Evaluate the Safety, Bioavailability and Pharmacokinetics of Two Formulations of C1-esterase Inhibitor Administered Intravenously
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- CSL Behring
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Incidence of adverse events (AEs) within 24 hours of CSL830 infusion
研究概览
简要总结
A new formulation of Berinert (CSL830) is being investigated for the management of hereditary angioedema (HAE). The main aim of the study is to assess the safety of a single 1500 IU dose of the new formulation of Berinert. This study will also look at the pharmacokinetics of CSL830 relative to Berinert currently on the market.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects without clinically significant medical conditions or laboratory abnormalities
- •Male or female subjects aged 18 to 45 years inclusive, at the time of informed consent
- •Non-smokers
- •Body mass index of 18.0 to 29.0 kg/m2 inclusive
排除标准
- •Previous history of clinically significant arterial or venous thrombosis, current history of a clinically significant pro-thrombotic risk, or a clinically significant abnormality on laboratory thrombotic screen at the screening visit.
- •Known or suspected hypersensitivity to the investigational medicinal product (IMP), or to any excipients of the IMP.
- •Female subjects who started taking or changed dose of any hormonal contraceptive regimen or hormone replacement therapy (ie, estrogen/progesterone containing products) within 3 months before the screening visit.
- •Alcohol, drug, or medication abuse within one year before the study.
- •Female subjects of childbearing potential (eg, not post-menopausal) either not using, or not willing to use, a medically reliable method of contraception for the entire duration of the study, or have a vasectomized partner, or not sexually abstinent for the entire duration of the study, or not surgically sterile.
- •Participation in another clinical study (or use of another IMP) within 30 days (or 5 times the half-life, whichever is longer) before, or during, the study.
研究组 & 干预措施
CSL830, then Berinert
A single intravenous dose of CSL830 at 1500 IU, followed by a single intravenous dose of Berinert at 1500 IU.
干预措施: CSL830 (Biological)
CSL830, then Berinert
A single intravenous dose of CSL830 at 1500 IU, followed by a single intravenous dose of Berinert at 1500 IU.
干预措施: Berinert (Biological)
Berinert, then CSL830
A single intravenous dose of Berinert at 1500 units (1500 IU), followed by a single intravenous dose of CSL830 at 1500 IU.
干预措施: CSL830 (Biological)
Berinert, then CSL830
A single intravenous dose of Berinert at 1500 units (1500 IU), followed by a single intravenous dose of CSL830 at 1500 IU.
干预措施: Berinert (Biological)
结局指标
主要结局
Incidence of adverse events (AEs) within 24 hours of CSL830 infusion
时间窗: From the start of infusion to 24 hours after the end of infusion
次要结局
- Incidence of adverse events (AEs) within 10 days of the CSL830 infusion(From the start of infusion to 10 days after the infusion)
- Relative bioavailability of CSL830 versus Berinert - Cmax(240 hours)
- Relative bioavailability of CSL830 versus Berinert - AUC(240 hours)