Trials / Completed
CompletedNCT02453672
Pharmacokinetic, Safety, Tolerability, and Immunogenicity Study of SB8 in Healthy Male Subjects
A Randomised, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Three Formulations of Bevacizumab (SB8, EU Sourced Avastin®, and US Sourced Avastin®) in Healthy Male Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 119 (actual)
- Sponsor
- Samsung Bioepis Co., Ltd. · Industry
- Sex
- Male
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Three Formulations of Bevacizumab
Detailed description
A Randomised, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Three Formulations of Bevacizumab (SB8, EU Sourced Avastin®, and US Sourced Avastin®) in Healthy Male Subjects
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | SB8 | SB8, proposed bevacizumab biosimilar |
| BIOLOGICAL | EU sourced Avastin® | EU sourced Avastin® (bevacizumab, Roche Registration Ltd.) |
| BIOLOGICAL | US Sourced Avastin® | US Sourced Avastin® (bevacizumab, Roche Registration Ltd.) |
Timeline
- Start date
- 2015-04-01
- Primary completion
- 2015-09-01
- Completion
- 2015-09-01
- First posted
- 2015-05-25
- Last updated
- 2019-06-03
- Results posted
- 2019-06-03
Locations
1 site across 1 country: Belgium
Source: ClinicalTrials.gov record NCT02453672. Inclusion in this directory is not an endorsement.