drugset / Trial / NCT01884935

PK and PD Study of Natalizumab in Pediatric Subjects With RRMS

NCT01884935

Phase 1 Completed 13 enrolled Biogen
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

EvaluationDrugModalityDoseRoute
Subject natalizumab Monoclonal antibody 300 mg Intravenous