A randomized phase-I pharmacokinetic trial comparing the potential biosimilar tocilizumab (QX003S) with the reference product (Actemra^®) in Chinese healthy subjects.

ABSTRACT:

Purpose

QX003S is a biosimilar candidate for the reference tocilizumab, Actemra®. We investigated the tolerance, variability, and pharmacokinetics (PK) of QX003S biosimilar in healthy Chinese male subjects.

Design

A randomised, double-blind, two-arm, parallel study was performed to examine the bioequivalence of QX003S (8 mg/kg) with that of Actemra® as a reference drug.

Results

QX003S (N = 40) and Actemra® (N = 40) groups exhibited similar PK properties. The inter-subject variability ranged from 14.95% to 18.78%. The 90% confidence intervals of the ratios for C_max, AUC_0-t andAUC_0-∞ in both groups were within the range of 80-125%. After administration, the number of subjects who tested positive for anti-drug antibodies (AD

SUBMITTER: Zhang H 

PROVIDER: S-EPMC7919877 | biostudies-literature | 2021 Dec

REPOSITORIES: biostudies-literature