Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB2 in Healthy Subjects
1期
已完成
NCT01922336
| 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 | 159 人 |
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| 干预（药物） | SB2, EU Remicade, US Remicade |
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| 开始日期 | 2013年7月 |
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| 完成日期 | 2013年10月 |
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| 结果公布日 | 2019年2月21日 |
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摘要
The purpose of this study is to compare the pharmacokinetics, safety, tolerability and immunogenicity of SB2 and Remicade (EU sourced Remicade and US sourced Remicade) in healthy subjects.
Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf)
71 days · h·μg/mL
| SB2 (Proposed Infliximab Biosimilar) | 38702.8145 ± 11113.62172 h·μg/mL |
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| EU Remicade | 39359.7493 ± 12332.41615 h·μg/mL |
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| US Remicade | 39270.1707 ± 10064.08853 h·μg/mL |
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Maximum Serum Concentration (Cmax)
71 days · μg/mL
| SB2 (Proposed Infliximab Biosimilar) | 126.9975 ± 16.89586 μg/mL |
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| EU Remicade | 126.2377 ± 17.88151 μg/mL |
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| US Remicade | 129.1508 ± 18.75573 μg/mL |
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Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast)
71 days · h·μg/mL
| SB2 (Proposed Infliximab Biosimilar) | 36862.4180 ± 9132.75342 h·μg/mL |
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| EU Remicade | 37022.3524 ± 9398.42182 h·μg/mL |
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| US Remicade | 37367.5577 ± 8332.05331 h·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。