A randomised, single-blind, single-dose, three-arm, parallel-group study in healthy subjects to demonstrate pharmacokinetic equivalence of ABP 501 and adalimumab.

ABSTRACT:

Objective

To demonstrate pharmacokinetic (PK) similarity of biosimilar candidate ABP 501 relative to adalimumab reference product from the USA and European Union (EU) and evaluate safety, tolerability and immunogenicity of ABP 501.

Methods

Randomised, single-blind, single-dose, three-arm, parallel-group study; healthy subjects were randomised to receive ABP 501 (n=67), adalimumab (USA) (n=69) or adalimumab (EU) (n=67) 40 mg subcutaneously. Primary end points were area under the serum concentration-time curve from time 0 extrapolated to infinity (AUC_inf) and the maximum observed concentration (C_max). Secondary end points included safety and immunogenicity.

Results

AUC_inf and C_max were similar across the three groups. Geometri

SUBMITTER: Kaur P 

PROVIDER: S-EPMC5445997 | biostudies-literature | 2017 Mar

REPOSITORIES: biostudies-literature