Comparative pharmacokinetics of an adalimumab biosimilar SB5 administered via autoinjector or prefilled syringe in healthy subjects.

ABSTRACT:

Purpose

The objective of this study was to demonstrate comparable pharmacokinetic (PK), safety, and tolerability parameters of the adalimumab biosimilar SB5 administered via autoinjector (AI) pen or prefilled syringe (PFS).

Patients and methods

In this phase 1, randomized, open-label, single-dose, parallel-group study, healthy subjects aged 18-55 years were randomized 1:1 to a single dose of 40 mg SB5 delivered subcutaneously via AI or PFS. PK parameters, safety, and tolerability were assessed for 57 days post-dose. The primary endpoint was area under the curve (AUC) of the concentration-time curve from zero to infinity (AUC_inf) and from zero to last quantifiable concentration (AUC_last) and maximum serum concentration (C_max). Equivalence was

SUBMITTER: Shin D 

PROVIDER: S-EPMC6225915 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature