Trials / Completed
CompletedNCT02075073
Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB3 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 Trastuzumab (SB3, EU Sourced Herceptin® and US Sourced Herceptin®) in Healthy Male Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 109 (actual)
- Sponsor
- Samsung Bioepis Co., Ltd. · Industry
- Sex
- Male
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to compare the pharmacokinetics, safety, tolerability and immunogenicity of SB3 and Herceptin® (EU sourced Herceptin® and US sourced Herceptin®) in healthy male subjects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | SB3 | |
| BIOLOGICAL | EU sourced Herceptin® | |
| BIOLOGICAL | US sourced Herceptin® |
Timeline
- Start date
- 2014-02-01
- Primary completion
- 2014-04-01
- Completion
- 2014-04-01
- First posted
- 2014-03-03
- Last updated
- 2017-09-14
- Results posted
- 2016-09-29
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT02075073. Inclusion in this directory is not an endorsement.