Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB4 in Healthy Male Subjects
Фаза 1
Завершено
NCT01865552
| Заболевание | Healthy |
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| Фаза | Фаза 1 |
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| Спонсор | Samsung Bioepis Co., Ltd. |
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| Статус | Завершено |
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| Участники | 138 участн. |
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| Вмешательство | SB4, EU sourced Enbrel, US sourced Enbrel |
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| Дата начала | 05.2013 |
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| Дата завершения | 08.2013 |
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| Публикация результатов | 4.06.2019 |
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Кратко
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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