Study to compare the PK of sc Mepolizumab from safety syringe vs AI
Research type
Research Study
Full title
An open label, randomised, three arm, single dose, multicentre, parallel group study in healthy subjects to compare the pharmacokinetics of subcutaneous mepolizumab when delivered as a liquid drug product in a safety syringe or an auto injector with a reconstituted lyophilised drug product from a vial
IRAS ID
218150
Contact name
Muna Albayaty
Contact email
Sponsor organisation
GlaxoSmithKline
Eudract number
2016-002405-19
Duration of Study in the UK
0 years, 6 months, 6 days
Research summary
This is an open-label, randomised, three arm, single dose, parallel group clinical trial to compare the pharmacokinetics (PK) of mepolizumab when administered subcutaneously using three different mepolizumab treatments. The trial will also evaluate the safety, tolerability and immunogenicity of mepolizumab. In addition, the trial will explore the effect of the study drug on blood eosinophil count (a type of white blood cell associated with allergic reactions). The use and functionality of the pre-filled injection devices will also be evaluated. The trial will be conducted at multiple clinical sites, enrolling healthy male and female subjects. The study will comprise a screening visit and a single dose treatment period followed by 15 out-patient visits (including the final follow-up visit on Day 85).
This is not a first-in-human study. Mepolizumab has been administered in several clinical trials, including research studies in asthma patients. Recently, the lyophilized drug product (Mepolizumab for Injection) was approved in a number of markets including the European Union. Before administration, the lyophilized drug product must be reconstituted with water for injection using aseptic techniques. Mepolizumab for Injection should be administered by a health care professional (standard subcutaneous injection). Currently, a liquid drug product (Mepolizumab Injection) provided as a ready-to-use pre-filled syringe assembled into either a safety syringe or an autoinjector has been developed. Administration of the liquid drug product from pre-filled syringes will be more convenient and may allow the ultimate goal of patient self-administration.
Mepolizumab is being investigated for treatment of eosinophilic-associated diseases, including severe eosinophilic asthma. The study drug is thought to block specific mediators on eosinophils, resulting in a reduction of exacerbations/flares and in the maintenance doses of oral corticosteroid treatment. Current data from patient studies demonstrated a reduction in asthma exacerbations, improvements in asthma control and quality of life, as well as improvements in lung function and a reduction in oral corticosteroid use.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
16/SC/0608
Date of REC Opinion
24 Jan 2017
REC opinion
Further Information Favourable Opinion