GSK3915393 – first doses in humans
Research type
Research Study
Full title
A Randomized, Placebo Controlled, Double Blind, Single and Repeat Dose Escalation Phase 1 Study to Evaluate Safety, Tolerability, and Pharmacokinetics of GSK3915393 in Healthy Participants and to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmocodynamics of GSK3915393 in Patients with Celiac Disease
IRAS ID
1003407
Contact name
Malcolm Boyce
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Limited
Eudract number
2020-003213-36
Research summary
Summary of Research
The study medicine (GSK3915393) is an experimental medicine being evaluated for
coeliac disease. In coeliac disease, the immune system reacts to gluten, damaging the
lining of the gut and causing symptoms including diarrhoea, abdominal pain, bloating,
flatulence, indigestion, constipation, and tiredness. GSK3915393 blocks an enzyme
called TG2, which chemically modifies gluten. In people with coeliac disease, the
modified gluten attaches to proteins found on immune cells, triggering an immune
response. We hope that GSK3915393 will decrease the activity of TG2 and stop the
immune system from reacting to gluten.
This study will assess the safety, tolerability and blood levels of single and repeat doses
of GSK3915393 in up to 12 healthy adults (Part A), up to 36 healthy adults (Part B) and
20 adults with coeliac disease (Part C). How the body gets rid of GSK3915393, whether
it affects heart rhythm, and the effect of food will also be assessed. In Part C, participants
will eat a breakfast containing gluten for 3 days in a row and we will assess whether
GSK3915393 affects the body’s reaction to gluten.
GSK3915393 has never been given to humans before, so we will start with a small dose
and increase the dose as the study progresses. Most doses will be given as capsules (by
mouth); in 1 session in Part A participants will be given a tiny ‘microdose’ by slow
injection into a vein.
In Part A, participants will have 5 study sessions and stay on the ward for up to 3 nights
in each session. Parts B and C participants will have 1 session and stay on the ward for
15 nights. All participants will have 2–3 outpatient visits.
A pharmaceutical company (GlaxoSmithKline) is funding the study, which will take place
at 1 centre in London.Summary of Results
The sponsors are in the process of publishing the summary of results on clincialtrails.gov; however, the sponsor have not provided a lay summary of the results.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
20/SC/0317
Date of REC Opinion
22 Oct 2020
REC opinion
Further Information Favourable Opinion