Trials / Completed
CompletedNCT01922336
Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB2 in Healthy Subjects
A Randomised, Single-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Three Formulations of Infliximab (SB2, EU Sourced Remicade® and US Sourced Remicade®) in Healthy Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 159 (actual)
- Sponsor
- Samsung Bioepis Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | SB2 | IV infusion |
| BIOLOGICAL | EU Remicade | IV infusion |
| BIOLOGICAL | US Remicade | IV infusion |
Timeline
- Start date
- 2013-07-01
- Primary completion
- 2013-10-01
- Completion
- 2013-10-01
- First posted
- 2013-08-14
- Last updated
- 2019-02-21
- Results posted
- 2019-02-21
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT01922336. Inclusion in this directory is not an endorsement.