Asthma Clinical Trial
Official title:
A Multicenter, Randomized, Open-Label, Parallel Group Phase 1 Pharmacokinetic Comparability Study of Benralizumab Administrated Using Accessorized Pre-Filled Syringe (APFS) or Autoinjector (AI) in Healthy Volunteers.
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.
A study of descriptive comparison of benralizumab PK by weight and injection site.
This study will be a multicenter, randomized, open-label, parallel group Phase 1 study
designed to compare benralizumab PK exposure in healthy subjects following single
subcutaneous (SC) administration of fixed 30 mg dose of benralizumab by using APFS and
single-use AI. Eligible subjects will be healthy subjects aged 18 to 55 years, with a body
weight of 55 to 100 kg and a body mass index of 18 to 29.9 kg/m2 . A total of 180 subjects
will be randomized. Randomization will be stratified by weight group (55 to 69.9 kg, 70 to
84.9 kg and 85 to 100 kg), and within each of the 3 weight groups, subjects will be
randomized 1:1:1:1:1:1 to 1 of the 6 combinations of treatment (APFS or AI) with injection
site (upper arm, abdomen or thigh), presented in Table 1. This study will be performed at 2
study centers.
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