Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB4 in Healthy Male Subjects
第1相
完了
NCT01865552
| 対象疾患 | Healthy |
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| 相 | 第1相 |
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| スポンサー | Samsung Bioepis Co., Ltd. |
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| ステータス | 完了 |
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| 参加者数 | 138 名 |
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| 介入（薬剤） | SB4, EU sourced Enbrel, US sourced Enbrel |
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| 開始日 | 2013年5月 |
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| 完了日 | 2013年8月 |
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| 結果公開日 | 2019年6月4日 |
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概要
The purpose of this study is to compare the pharmacokinetics, safety and immunogenicity of SB4 and Enbrel (EU sourced Enbrel and US sourced Enbrel) in healthy male subjects.
Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf)
0 to 480 hours post-dose · µg·h/mL
| SB4 in Part A | 769.069 ± 243.9039 µg·h/mL |
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| EU Sourced Enbrel in Part A | 771.680 ± 226.2874 µg·h/mL |
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| SB4 in Part B | 834.680 ± 242.7652 µg·h/mL |
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| US Sourced Enbrel in Part B | 810.054 ± 195.9770 µg·h/mL |
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| EU Sourced Enbrel in Part C | 790.110 ± 274.2535 µg·h/mL |
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| US Sourced Enbrel in Part C | 768.228 ± 238.1251 µg·h/mL |
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Maximum Serum Concentration (Cmax)
0 to 480 hours post-dose · μg/mL
| SB4 in Part A | 3.607 ± 1.4298 μg/mL |
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| EU Sourced Enbrel in Part A | 3.435 ± 1.2390 μg/mL |
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| SB4 in Part B | 3.869 ± 1.3251 μg/mL |
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| US Sourced Enbrel in Part B | 3.613 ± 1.0252 μg/mL |
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| EU Sourced Enbrel in Part C | 3.720 ± 1.5444 μg/mL |
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| US Sourced Enbrel in Part C | 3.575 ± 1.4833 μg/mL |
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