Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB5 in Healthy Subjects
1期
已完成
NCT02144714
| 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 | 189 人 |
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| 干预（药物） | SB5, EU sourced Humira®, US sourced Humira® |
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| 开始日期 | 2014年5月 |
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| 完成日期 | 2014年9月 |
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| 结果公布日 | 2018年9月21日 |
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摘要
The purpose of this study is to compare the pharmacokinetics, safety, tolerability, and immunogenicity of SB5 and Humira (EU sourced Humira® and US sourced Humira®) in healthy subjects.
Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf)
0 to 1680 hours post-dose · μg·h/mL
| SB5 (Proposed Adalimumab Biosimilar) | 2405.6 ± 825.93 μg·h/mL |
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| EU Sourced Humira® | 2435.5 ± 915.66 μg·h/mL |
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| US Sourced Humira® | 2422.6 ± 957.00 μg·h/mL |
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Maximum Serum Concentration (Cmax)
pre-dose (0 h) and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 336, 504, 672, 1008, 1344, and 1680 h post-dose · μg/mL
| SB5 (Proposed Adalimumab Biosimilar) | 3.365 ± 0.9796 μg/mL |
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| EU Sourced Humira® | 3.548 ± 1.1811 μg/mL |
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| US Sourced Humira® | 3.488 ± 1.0779 μg/mL |
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Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast)
0 to 1680 hours post-dose · μg·h/mL
| SB5 (Proposed Adalimumab Biosimilar) | 2125.7 ± 689.92 μg·h/mL |
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| EU Sourced Humira® | 2096.0 ± 791.28 μg·h/mL |
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| US Sourced Humira® | 2101.9 ± 795.56 μg·h/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。