Randomised, phase I pharmacokinetic study of adalimumab biosimilar CT-P17 (40 mg/0.4 mL) by autoinjector and prefilled syringe in healthy subjects.

ABSTRACT:

Aims

To evaluate pharmacokinetic equivalence and preliminary safety of the adalimumab biosimilar CT-P17 administered via autoinjector (CT-P17 AI) or prefilled syringe (CT-P17 PFS) in healthy subjects.

Methods

This phase I, open-label study (ClinicalTrials.gov: NCT04295356) randomised subjects (1:1) to receive a single 40-mg (100 mg/mL) dose of CT-P17 AI or CT-P17 PFS. Primary endpoint was pharmacokinetic equivalence of CT-P17 AI to CT-P17 PFS for: area under the concentration-time curve from time zero to infinity (AUC_0-inf ); area under the concentration-time curve from time zero to the last quantifiable concentration (AUC_0-last ); maximum serum concentration (C_max ). Equivalence was determined if the 90% confidence interval for the geometric

SUBMITTER: Davidson A 

PROVIDER: S-EPMC8597139 | biostudies-literature | 2021 Nov

REPOSITORIES: biostudies-literature