Study to compare the PK of Benralizumab when injected with APFS vs AI
Research type
Research Study
Full 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
IRAS ID
215261
Contact name
Pablo Forte Soto
Contact email
Sponsor organisation
AstraZeneca
Eudract number
2016-002955-52
Duration of Study in the UK
0 years, 5 months, 20 days
Research summary
This is a randomised, open-label, parallel group clinical trial to compare the pharmacokinetics (PK) of benralizumab when administrated subcutaneously using an accessorised pre-filled syringe device or an autoinjector. Pharmacokinetics refers to how the study medication is absorbed (taken up into the body), metabolised (chemically broken down), distributed through the body, and excreted (removed form the body). The trial will also evaluate the PK of benralizumab when administered to various anatomical injection sites and in subjects with different body weight ranges, as well as the safety, tolerability and immunogenicity of benralizumab. The trial will be conducted in healthy male and female (non-childbearing potential) subjects, at two different clinical units. The study will comprise a screening visit, one treatment period, 8 out-patient visits and an end-of-treatment visit on Day 57 (Week 8).
This is not a first-time-in-human study. Benralizumab has been administered to healthy subjects in several studies, as well as to patients in two large efficacy studies involving severe asthmatics. Benralizumab is being developed by the sponsor for the treatment of asthma. The study drug is thought to bind to a specific subunit on the target cell, with resulting depletion of blood and airway eosinophils (a type of white blood cell). Benralizumab has been shown to have benefit across a range of asthma outcomes including reductions in asthma exacerbations, improvements in lung function and reduction in symptoms.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
16/SC/0571
Date of REC Opinion
22 Nov 2016
REC opinion
Favourable Opinion