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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
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.
Details
| Lead sponsor | Samsung Bioepis Co., Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 189 |
| Start date | 2014-05 |
| Completion | 2014-09 |
Conditions
- Healthy
Interventions
- SB5
- EU sourced Humira®
- US sourced Humira®
Primary outcomes
- Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) — 0 to 1680 hours post-dose
pre-dose (0 h) and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 336, 504, 672, 1008, 1344, and 1680 h post-dose - Maximum Serum Concentration (Cmax) — pre-dose (0 h) and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 336, 504, 672, 1008, 1344, and 1680 h post-dose
pre-dose (0 h) and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 336, 504, 672, 1008, 1344, and 1680 h post-dose - Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) — 0 to 1680 hours post-dose
pre-dose (0 h) and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 336, 504, 672, 1008, 1344, and 1680 h post-dose
Countries
Germany