Similar Pharmacokinetics of the Adalimumab (Humira^®) Biosimilar BI 695501 Whether Administered via Subcutaneous Autoinjector or Prefilled Syringe (VOLTAIRE^®-AI and VOLTAIRE^®-TAI): Phase 1, Randomized, Open-Label, Parallel-Group Trials.

ABSTRACT:

Introduction

BI 695501 has shown similar efficacy, safety, and immunogenicity to the adalimumab reference product, Humira^®. We present two phase 1 studies comparing the pharmacokinetics, safety, and immunogenicity of BI 695501 delivered via autoinjector (AI) vs. prefilled syringe (PFS).

Methods

Both trials were randomized, open-label, parallel-group studies undertaken in subjects aged ≥ 18-65 years. VOLTAIRE^®-AI (NCT02606903) recruited healthy, Caucasian, male, non-athletic volunteers with BMI ≥ 18 to ≤ 30 kg/m². VOLTAIRE^®-TAI (NCT02899338) recruited healthy men and women with BMI > 17.5 to < 35 kg/m². In both studies, a single dose of BI 695501 40 mg was administered via AI or PFS to the abdomen (VOLTAIRE^®-AI

SUBMITTER: Ramael S 

PROVIDER: S-EPMC6251849 | biostudies-literature | 2018 Dec

REPOSITORIES: biostudies-literature