A Phase 1, Multicenter, Open-Label, Single-Arm, Multiple Dose Study to Evaluate the the Pharmacokinetics and Pharmacodynamics of Natalizumab in Pediatric Subjects With Relapsing Remitting Multiple Sclerosis (RMS)

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.

本研究的主要目的为明确复发缓解型多发性硬化（relapsing-remitting multiple sclerosis, RRMS）儿科受试者接受那他珠单抗多次给药后的药代动力学（pharmacokinetic, PK）特征。次要研究目标包括：其一，表征以α4整合素结合为评价依据的那他珠单抗药效动力学（pharmacodynamic, PD）特征；其二，探索儿科人群中那他珠单抗多次给药的安全性与耐受性。