Trials / Completed
CompletedNCT02144714
Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB5 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 Adalimumab (SB5, EU Sourced Humira® and US Sourced Humira®) in Healthy Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 189 (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 SB5 and Humira (EU sourced Humira® and US sourced Humira®) in healthy subjects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | SB5 | |
| BIOLOGICAL | EU sourced Humira® | |
| BIOLOGICAL | US sourced Humira® |
Timeline
- Start date
- 2014-05-01
- Primary completion
- 2014-09-01
- Completion
- 2014-09-01
- First posted
- 2014-05-22
- Last updated
- 2018-11-14
- Results posted
- 2018-09-21
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT02144714. Inclusion in this directory is not an endorsement.