drugset / Trial / NCT02074800
A Study to Assess the Safety and Pharmacokinetics of a Single Intravenous Administration of CNTO 328 Derived From 2 Different Cell Lines in Healthy Participants
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of Part 1 of this study is to assess the safety and tolerability of 2 dose levels (1.4 and 2.8 mg/kg) of CHO-derived CNTO 328 and Sp2/0-derived CNTO 328. The purpose of Part 2 of this study is to access the pharmacokinetics (what the body does to the study medication) comparability of the 1.4 mg/kg dose of CHO-derived CNTO 328 and Sp2/0-derived CNTO 328.
Timeline
- Start
- 2008-06
- Primary completion
- 2009-06
- Completion
- 2009-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Siltuximab | Monoclonal antibody | 1.4 mg/kg | Intravenous |
| Subject | Siltuximab | Monoclonal antibody | 2.8 mg/kg | Intravenous |
Indications
No indication recorded.