A Phase 1, Randomized, Open-label, Parallel-group Study to Compare the Pharmacokinetic Properties of CSL312 Administered by Subcutaneous Prefilled Syringe Assembled to Autoinjector to Prefilled Syringe Assembled to Needle Safety Device in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- CSL Behring
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Maximum plasma concentration (Cmax) of CSL312
研究概览
简要总结
This is an open-label, parallel-group, phase 1, single center study to assess the relative bioavailability of CSL312 administered subcutaneously via a prefilled syringe assembled to an autoinjector compared to a prefilled syringe assembled to a needle safety device in healthy, adult subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Male or female 18 to 55 years of age
- •Body weight in the range of ≥ 50 kg and ≤ 100 kg, with a body mass index (BMI) of ≥ 18 kg/m2 and ≤ 30 kg/m2
排除标准
- •Received any live viral or bacterial vaccinations within 8 weeks of Screening or is expected to receive any live virus or bacterial vaccinations during the study or up to 4 months after last administration of the investigational product.
- •Evidence of current active infection, including severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2).
- •Blood pressure or pulse rate measurements outside the normal range for the subject's age
研究组 & 干预措施
CSL312 AI Abdomen
CSL312 administered subcutaneously (SC) in the abdomen via a prefilled syringe assembled to an autoinjector (AI)
干预措施: CSL312 (Drug)
CSL312 AI Thigh
CSL312 administered SC in the thigh via a prefilled syringe assembled to an AI
干预措施: CSL312 (Drug)
CSL312 AI Arm
CSL312 administered SC in the upper arm via a prefilled syringe assembled to an AI
干预措施: CSL312 (Drug)
CSL312 NSD Abdomen
CSL312 administered SC in the abdomen via a prefilled syringe assembled to a needle safety device (NSD)
干预措施: CSL312 (Drug)
CSL312 NSD Thigh
CSL312 administered SC in the thigh via a prefilled syringe assembled to a NSD
干预措施: CSL312 (Drug)
CSL312 NSD Arm
CSL312 administered SC in the upper arm via a prefilled syringe assembled to a NSD
干预措施: CSL312 (Drug)
结局指标
主要结局
Maximum plasma concentration (Cmax) of CSL312
时间窗: Up to 85 days post-dose
Area under the concentration-time curve (AUC) from time 0 extrapolated to infinite time (AUC0-inf) of CSL312
时间窗: Up to 85 days post-dose
次要结局
- Number and percentage of subjects with clinically significant laboratory abnormalities that are reported as AEs(Up to 85 days post-dose)
- Number and percentage of subjects experiencing adverse events (AEs)(Up to 85 days post-dose)
- Number and percentage of subjects experiencing adverse events of special interest (AESIs)(Up to 85 days post-dose)
- Apparent volume of distribution (Vz/F) of CSL312(Up to 85 days post-dose)
- Number and percentage of subjects experiencing serious adverse events (SAEs)(Up to 85 days post-dose)
- Time to maximum plasma concentration (Tmax) of CSL312(Up to 85 days post-dose)
- Half-life (t1/2) of CSL312(Up to 85 days post-dose)
- Apparent clearance (CL/F) of CSL312(Up to 85 days post-dose)
- Number and percentage of subjects developing Anti-CSL312 antibodies(Up to 85 days post-dose)
- Number and percentage of subjects with injection site reactions by severity(Up to 48 hours post-injection)
- AUC from time 0 to the last measurable concentration (AUC0-last) of CSL312(Up to 85 days post-dose)