drugset / Trial / NCT01884935
PK and PD Study of Natalizumab in Pediatric Subjects With RRMS
NaSingle-groupOpen-labelTreatment
Summary
The primary objective of the study is to determine the pharmacokinetic (PK) profile of multiple doses of natalizumab in pediatric subjects with relapsing-remitting multiple sclerosis (RRMS). The secondary objectives are as follows: to characterize the pharmacodynamic (PD) profile of natalizumab (as defined by α4 integrin binding) and to explore the safety and tolerability of multiple doses of natalizumab in the pediatric population.
Timeline
- Start
- 2013-07
- Primary completion
- 2014-09
- Completion
- 2014-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | natalizumab | Monoclonal antibody | 300 mg | Intravenous |