Pharmacokinetic, Safety, Tolerability, and Immunogenicity Study of SB8 in Healthy Male Subjects
1期
已完成
NCT02453672
| 适应症 | Healthy |
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| 分期 | 1期 |
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| 申办方 | Samsung Bioepis Co., Ltd. |
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| 状态 | 已完成 |
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| 受试者人数 | 119 人 |
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| 干预（药物） | SB8, EU sourced Avastin®, US Sourced Avastin® |
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| 开始日期 | 2015年4月 |
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| 完成日期 | 2015年9月 |
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| 结果公布日 | 2019年6月3日 |
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摘要
Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Three Formulations of Bevacizumab
Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf)
0 to 2016 hours after start of infusion · h·μg/mL
| SB8 (Proposed Bevacizumab Biosimilar) | 25354.4 ± 4833.10 h·μg/mL |
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| EU Sourced Avastin® | 28896.8 ± 6221.62 h·μg/mL |
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| US Sourced Avastin® | 28684.8 ± 5425.14 h·μg/mL |
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Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast)
0 to 2016 hours after start of infusion · h·μg/mL
| SB8 (Proposed Bevacizumab Biosimilar) | 24199.2 ± 4367.53 h·μg/mL |
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| EU Sourced Avastin® | 27342.2 ± 5374.53 h·μg/mL |
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| US Sourced Avastin® | 27177.9 ± 4770.93 h·μg/mL |
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Maximum Serum Concentration (Cmax)
0 to 2016 hours after start of infusion · μg/mL
| SB8 (Proposed Bevacizumab Biosimilar) | 76.259 ± 14.6999 μg/mL |
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| EU Sourced Avastin® | 76.059 ± 11.7053 μg/mL |
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| US Sourced Avastin® | 76.485 ± 16.9916 μg/mL |
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本页整理自 ClinicalTrials.gov 的公开数据，不构成医疗建议，也不构成投资建议。请务必咨询专业医师。