GSK3511294 – first doses in humans
Research type
Research Study
Full title
A randomised double-blind (sponsor open), placebo-controlled, single ascending dose, First Time in Human study in participants with mild to moderate asthma to assess safety, tolerability, immunogenicity, pharmacokinetics and pharmacodynamics of GSK3511294 administered subcutaneously.
IRAS ID
230178
Contact name
Dave Singh
Contact email
Sponsor organisation
GlaxoSmithKline
Eudract number
2016-004256-30
Duration of Study in the UK
1 years, 4 months, 0 days
Research summary
One of the causes of severe asthma is high levels of some white blood cells, called eosinophils, in the body. This causes inflammation (swelling) in the airways of the lungs, which can make breathing difficult. GlaxoSmithKline is investigating a study drug that reduces levels of eosinophils, and subsequently the amount of inflammation in the lungs. It has never been given to people before. It has only been tested in animals and in the laboratory.
This study will investigate safety, how much study drug gets into the blood, how long the body takes to get rid of it, and how it affects eosinophil levels and levels other markers relevant to asthma, in the blood.
Other medicines are available that work in a similar way to the study drug, but we hope the study drug can be taken less often; every 6 months, instead of every month.
Between 48 and 72 participants with mild to moderate asthma with eosinophils ≥200 cells/μL will take part in this study, at 6 clinical sites (4 in the UK and 2 in Germany).
Participants will be divided into 5 groups; each receiving a different single dose subcutaneously (injection under the skin) of the study drug or placebo (dummy medication).
In each group, one placebo and one study drug participant will be dosed before the remaining participants. If no safety issues are identified after 72 hours, the remaining patients can be dosed.
Assessments will comprise: Medical history, heart monitoring, adverse events monitoring, vital signs, physical exam, blood and urine tests, asthma test and questionnaire.The study consists of blood eosinophils pre-screening, up to 4 weeks of screening, 4 days of inpatient period and up to 40 weeks of post-dose assessments.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
17/NW/0484
Date of REC Opinion
29 Sep 2017
REC opinion
Further Information Favourable Opinion