NCT04580654已完成1 期
A 2-Part, Phase 1, Single Center, Open-label, Single Ascending Dose Study to Investigate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Subcutaneous and Intravenous CSL312 in Healthy Adult Japanese and Caucasian Subjects
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- CSL Behring
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Maximum plasma concentration (Cmax) of CSL312 after subcutaneous dosing
研究概览
简要总结
This will be a 2- part, phase 1, open-label, single center, single ascending dose study to investigate the pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of subcutaneous (SC) and intravenous (IV) administration of CSL312 in healthy adult Japanese and Caucasian subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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 Caucasian and Japanese male or female subjects 18 to 55 years old (inclusive) that meet the following criteria at Screening:
- •Japanese subjects defined as being born in Japan, having not lived outside of Japan for more than 10 years, and having both parents and four grandparents who are of Japanese ancestry.
- •Caucasian subjects, defined as having both parents and four grandparents descended from and of the peoples of Europe, the Middle East, or North Africa, who are body weight-matched (± 15%) 1:1 with Japanese subjects.
- •Body weight in the range of ≥ 50 kg and ≤ 100 kg
- •Body mass index of ≥ 18 kg/m2 and ≤ 30 kg/m2
排除标准
- •Positive serology test for human immunodeficiency virus (HIV)-1 / 2 antibody, hepatitis B virus (HBV) surface antigen (HBsAg) or hepatitis C virus (HCV) antibody.
- •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.
- •Evidence of current active infection.
- •Known malignancy or a history of malignancy in the past 5 years .
- •Blood pressure or pulse rate measurements outside the normal range for the subject's age.
- •Female subject of childbearing potential or fertile male subject either not using or not willing to use an acceptable method of contraception
- •Pregnant, breastfeeding, or not willing to cease breastfeeding.
- •Donation or loss of more than 500 mL of blood within 3 months, or donated plasma within 7 days
- •History of clinically significant arterial or venous thrombosis, bleeding disorder, or any abnormal coagulation test result
研究组 & 干预措施
CSL312 (Cohort 4, high dose)
Experimental
Factor XIIa antagonist monoclonal antibody administered intravenously
干预措施: CSL312 (Biological)
CSL312 (Cohort 3, low dose)
Experimental
Factor XIIa antagonist monoclonal antibody administered intravenously
干预措施: CSL312 (Biological)
CSL312 (Cohort 2, high dose)
Experimental
Factor XIIa antagonist monoclonal antibody administered subcutaneously
干预措施: CSL312 (Biological)
CSL312 (Cohort 1b, low dose)
Experimental
Factor XIIa antagonist monoclonal antibody administered subcutaneously
干预措施: CSL312 (Biological)
CSL312 (Cohort 1a, low dose)
Experimental
Factor XIIa antagonist monoclonal antibody administered subcutaneously
干预措施: CSL312 (Biological)
结局指标
主要结局
Maximum plasma concentration (Cmax) of CSL312 after subcutaneous dosing
时间窗: Up to 85 days postdose
Area under the curve (AUC) from time 0 extrapolated to infinity (AUC0-inf) of CSL312 after subcutaneous dosing
时间窗: Up to 85 days postdose
次要结局
- Tmax of CSL312 after intravenous dosing(Up to 85 days postdose)
- AUC0-last of CSL312 after intravenous dosing(Up to 85 days postdose)
- AUC0-inf of CSL312 after intravenous dosing(Up to 85 days postdose)
- Mean FXIIa-mediated kallikrein activity(Up to 85 days postdose)
- Number of subjects experiencing adverse events (AEs)(Up to 85 days postdose)
- Percentage of subjects experiencing AEs(Up to 85 days postdose)
- Percentage of subjects experiencing Anti-CSL312 antibodies(Up to 85 days postdose)
- Apparent clearance (CL/F) of CSL312 after subcutaneous dosing(Up to 85 days postdose)
- Volume of distribution (Vd) of CSL312 after intravenous dosing(Up to 85 days postdose)
- Percentage of subjects experiencing AESIs(Up to 85 days postdose)
- Number of subjects with injection / infusion site reaction by severity(Up to 48 hours after start of infusion or injection)
- Area under the concentration-time curve from time 0 to the last measurable concentration (AUC0-last) of CSL312 after subcutaneous dosing(Up to 85 days postdose)
- Half-life (t1/2) of CSL312 after subcutaneous dosing(Up to 85 days postdose)
- Percentage of subjects experiencing SAEs(Up to 85 days postdose)
- Number of subjects experiencing adverse events of special interest (AESIs)(Up to 85 days postdose)
- Time to maximum concentration (Tmax) of CSL312 after subcutaneous dosing(Up to 85 days postdose)
- Apparent volume of distribution (Vz/F) of CSL312 after subcutaneous dosing(Up to 85 days postdose)
- Clearance (CL) of CSL312 after intravenous dosing(Up to 85 days postdose)
- Number of subjects experiencing serious adverse events (SAEs)(Up to 85 days postdose)
- Cmax of CSL312 after intravenous dosing(Up to 85 days postdose)
- t1/2 of CSL312 after intravenous dosing(Up to 85 days postdose)
- Number of subjects experiencing Anti-CSL312 antibodies(Up to 85 days postdose)
- Percentage of subjects with injection / infusion site reaction by severity(Up to 48 hours after start of infusion or injection)
研究者
研究点 (1)
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