drugset / Trial / NCT02456207
A Pharmacokinetic Study Comparing SCT400 And Rituximab in Patients With B-cell Non-Hodgkin's Lymphoma
RandomizedParallel-groupOpen-labelTreatment
Summary
The primary objective of the study is to assess the pharmacokinetic (PK) similarity of SCT400 versus rituximab (MabThera®) in patients with CD20+ B-cell Non-Hodgkin's Lymphoma. The secondary objective of the study is to evaluate the pharmacodynamics (PD) and safety of SCT400 versus rituximab (MabThera®), as well as the presence of human anti-chimeric antibodies (HACA).
Timeline
- Start
- 2015-05
- Primary completion
- 2015-12
- Completion
- 2015-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |
| Subject | ripertamab | Monoclonal antibody | 375 mg/m2 | Intravenous |