drugset / Trial / NCT01031836
A Study to Evaluate Safety and Tolerability of IV or SC Dose of MEDI-545 in Patients With Systemic Lupus Erythematosus.
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The purpose of the study is to evaluate the safety and tolerability of MEDI-545 in Japanese adult SLE patients. This will be done by collecting the data from 3 cohorts of IV doses and 1 cohort of SC doses.
Timeline
- Start
- 2009-11-25
- Primary completion
- 2012-11-07
- Completion
- 2016-07-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sifalimumab | Monoclonal antibody | 1 mg/kg | Intravenous |
| Subject | Sifalimumab | Monoclonal antibody | 3 mg/kg | Intravenous |
| Subject | Sifalimumab | Monoclonal antibody | 10 mg/kg | Intravenous |
| Subject | Sifalimumab | Monoclonal antibody | 100 mg | Intravenous |
| Subject | Sifalimumab | Monoclonal antibody | 600 mg | Intravenous |
| Subject | Sifalimumab | Monoclonal antibody | 1200 mg | Intravenous |