Bioavailability of Belimumab given by Syringe or Autoinjector
Research type
Research Study
Full title
A Randomized, Parallel-Group, Open-Label Study to Estimate the Relative Bioavailability, Tolerability and Safety of a Single Dose of Belimumab Administered Subcutaneously to Healthy Subjects by Prefilled Syringe or Autoinjector
IRAS ID
132912
Contact name
James Galloway
Contact email
Sponsor organisation
GlaxoSmithKline Research and Development Limited
Eudract number
2013-003691-12
Research summary
The purpose of this study is to compare the amount of Benlysta (belimumab) delivered by a prefilled syringe or an autoinjector (a device designed to deliver a single dose of drug). Benlysta is an approved drug for patients who have the disease known as lupus. Lupus affects the immune system of the body and can cause tissue damage particularly affecting the joints, skin, heart, kidneys and lungs. At the moment patients must attend a clinic to have the medication injected directly into the veins. A new formulation and method of delivery of the drug is being developed to enable patients to give themselves the drug at home. This study is about testing the best method of delivery.
Subjects will be admitted to the Unit up to 28 days after their screening visit for dosing. On the day of dosing subjects will be randomly assigned to a treatment group. There will be a 50/50 chance of being placed in either group. Each subject will then self administer a single dose of the study drug subcutaneously (under the skin) either into the abdomen or the thigh. Subjects will remain in the Unit overnight and be discharged the following day. There will be 12 outpatient visits for male subjects and 13 for female post discharge. At these visits information about how the study drug affects the body will be collected through a number of tests, procedures and questions.REC name
London - London Bridge Research Ethics Committee
REC reference
13/LO/1526
Date of REC Opinion
17 Dec 2013
REC opinion
Further Information Favourable Opinion