Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB4 in Healthy Male Subjects
Phase 1
Completed
NCT01865552
| Condition | Healthy |
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| Phase | Phase 1 |
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| Sponsor | Samsung Bioepis Co., Ltd. |
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| Status | Completed |
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| Enrollment | 138 participants |
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| Interventions | SB4, EU sourced Enbrel, US sourced Enbrel |
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| Start date | May, 2013 |
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| Completion date | Aug, 2013 |
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| Results posted | Jun 4, 2019 |
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Summary
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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Open in BENITIONS
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