Pharmacokinetic, Safety, Tolerability, and Immunogenicity Study of SB8 in Healthy Male Subjects
Phase 1
Completed
NCT02453672
| Condition | Healthy |
|---|
| Phase | Phase 1 |
|---|
| Sponsor | Samsung Bioepis Co., Ltd. |
|---|
| Status | Completed |
|---|
| Enrollment | 119 participants |
|---|
| Interventions | SB8, EU sourced Avastin®, US Sourced Avastin® |
|---|
| Start date | Apr, 2015 |
|---|
| Completion date | Sep, 2015 |
|---|
| Results posted | Jun 3, 2019 |
|---|
Summary
Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Three Formulations of Bevacizumab
Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf)
0 to 2016 hours after start of infusion · h·μg/mL
| SB8 (Proposed Bevacizumab Biosimilar) | 25354.4 ± 4833.10 h·μg/mL |
|---|
| EU Sourced Avastin® | 28896.8 ± 6221.62 h·μg/mL |
|---|
| US Sourced Avastin® | 28684.8 ± 5425.14 h·μg/mL |
|---|
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast)
0 to 2016 hours after start of infusion · h·μg/mL
| SB8 (Proposed Bevacizumab Biosimilar) | 24199.2 ± 4367.53 h·μg/mL |
|---|
| EU Sourced Avastin® | 27342.2 ± 5374.53 h·μg/mL |
|---|
| US Sourced Avastin® | 27177.9 ± 4770.93 h·μg/mL |
|---|
Maximum Serum Concentration (Cmax)
0 to 2016 hours after start of infusion · μg/mL
| SB8 (Proposed Bevacizumab Biosimilar) | 76.259 ± 14.6999 μg/mL |
|---|
| EU Sourced Avastin® | 76.059 ± 11.7053 μg/mL |
|---|
| US Sourced Avastin® | 76.485 ± 16.9916 μg/mL |
|---|
Open in BENITIONS
View on ClinicalTrials.gov
All trials
This page summarises publicly available data from ClinicalTrials.gov. It is not medical advice and not investment advice. Always consult a qualified healthcare professional.