A Single Center, Phase 1, Single-Ascending Dose, Open-Label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of CSL760, an Intravenous Anti-SARS-CoV-2 Hyperimmune Globulin, in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- CSL Behring
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Area under the concentration-time curve (AUC) from time 0 to the last measurable concentration (AUC0-last) of CSL760
研究概览
简要总结
CSL760 is a human hyperimmune product of the purified gamma immunoglobulin (IgG) fraction of human plasma containing polyvalent neutralizing antibodies to SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2). CSL is evaluating CSL760 as a passive immunotherapy for COVID-19 (Coronavirus Disease 2019).
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female 18 to 65 years of age
- •Female subjects must be postmenopausal or have a negative pregnancy test
- •Body weight in the range of ≥ 50 kg and ≤ 100 kg and have a body mass index of ≥ 18 to ≤ 32 kg/m2
排除标准
- •History of acute or chronic renal failure, thromboembolism, chronic respiratory illness, aseptic meningitis syndrome, or recurrent severe headaches or migraines.
- •Positive viral serology test for HIV -1/2 antibody, hepatitis B virus surface antigen, or hepatitis C virus antibody
- •Positive viral serology test for SARS-CoV-2 antibodies
- •Received any live viral or bacterial vaccinations within 8 weeks
- •Evidence of current active infection.
- •Known malignancy or a history of malignancy in the past 5 years
- •Female subject of childbearing potential or fertile male subject either not using or not willing to use an acceptable double barrier method of contraception to avoid pregnancy during the study
结局指标
主要结局
Area under the concentration-time curve (AUC) from time 0 to the last measurable concentration (AUC0-last) of CSL760
时间窗: Up to 91 days after end of IV infusion
Total immunoglobulin (IgG) concentration of CSL760
时间窗: At 0,0.5,1,2,6,12,24, and 48 hours, and 7,14,28,49, and 91 days after end of IV infusion
Maximum concentration (Cmax) of CSL760
时间窗: Up to 91 days after end of IV infusion
Time of Cmax (tmax) of CSL760
时间窗: Up to 91 days after end of IV infusion
次要结局
- Number of subjects with Serious adverse events (SAEs)(From start of infusion up to 91 days)
- Number of subjects with Clinically significant laboratory abnormalities that are reported as adverse events (AEs)(From start of infusion up to 91 days)
- Percent of subjects with SAEs(From start of infusion up to 91 days)
- Percent of subjects with Clinically significant laboratory abnormalities that are reported as AEs(From start of infusion up to 91 days)
- Number of subjects with Treatment-emergent adverse events (TEAEs)(From start of infusion up to 91 days)
- Percent of subjects with TEAEs(From start of infusion up to 91 days)