Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB2 in Healthy Subjects
Phase 1
Completed
NCT01922336
| 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 | 159 participants |
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| Interventions | SB2, EU Remicade, US Remicade |
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| Start date | Jul, 2013 |
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| Completion date | Oct, 2013 |
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| Results posted | Feb 21, 2019 |
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Summary
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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Open in BENITIONS
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