Pharmacokinetic Comparability of Benralizumab Using Accessorized Pre-Filled Syringe or Autoinjector in Healthy Volunteers

Summary

An open-label, single dose Pharmacokinetic (PK) comparability study to demonstrate comparable drug exposure following Subcutaneous benralizumab administration by using accessorized pre-filled syringe (APFS) or autoinjector (AI) devices.

Timeline

Start

2017-01-04

Primary completion

2017-07-13

Completion

2017-07-13

Publications

• Martin UJ, Fuhr R, Forte P, Barker P, Axley MJ, Aurivillius M, Yan L, Roskos L. Comparison of autoinjector with accessorized prefilled syringe for benralizumab pharmacokinetic exposure: AMES trial results. J Asthma. 2021 Jan;58(1):93-101. doi: 10.1080/02770903.2019.1663428. Epub 2019 Sep 20.

Drugs

Indications