APFS to AI PK Bridging Study in Anifrolumab
Research type
Research Study
Full title
A Multicenter, Randomized, Open-label, Parallel Phase 1 Comparability Study of Anifrolumab Administered using Accessorized Pre-Filled Syringe (APFS) or Autoinjector (AI) in Healthy Volunteers
IRAS ID
1004577
Contact name
Hayley West
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2021-004896-14
ISRCTN Number
ISRCTN93026854
Research summary
This study is a multi-center, randomized, open-label, parallel phase one comparability study in approximately 180 healthy male and female participants between the ages of 18 to 55.
The clinical trial will compare the delivery of the clinical trial medicine, a compound called Anifrolumab. Anifrolumab has been granted marketing authorization by the United States (US) Food and Drug Administration (FDA) for intravenous (IV) infusion, however, the use of an autoinjector (AI) (a type of automatic syringe) or an accessorized prefilled syringe (APFS) to deliver this clinical trial medicine has not been tested before. The participants will receive the clinical trial medicine once via AI or APFS.
The main purpose of the clinical trial is to examine the levels of the clinical trial medicine in blood after a single dosing under the skin using an AI compared to an APFS. The study will also look at how the clinical trial medicine is taken up, metabolised (chemically broken down), distributed through the body and excreted when it is injected in different places in your body (upper arm, lower abdomen, or front thigh) as well as the safety and tolerability of the clinical trial medicine when administered via AI versus APFS.
The trial comprises a screening Period of up to 28 days, one in-house stay of about 3 days and 8 outpatient visits.REC name
London - Surrey Borders Research Ethics Committee
REC reference
22/LO/0086
Date of REC Opinion
6 Apr 2022
REC opinion
Further Information Favourable Opinion