*FTiH study to evaluate single doses of GSK3888130B in healthy participants
Research type
Research Study
Full title
A Randomised, Double-Blind, Placebo Controlled, Single Dose Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK3888130B in Healthy Participants aged 18-55 inclusive.
IRAS ID
1003883
Contact name
Markas Marriott
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Limited
Eudract number
2021-002063-22
Research summary
GlaxoSmithKline (GSK) is developing a new drug (GSK3888130B) for the treatment of Multiple Sclerosis (MS). MS is a lifelong serious health condition that usually gets worse over time. In this disease, the body’s natural defence against illness (the immune system) damages and attacks the protective coverings of nerve cells in the brain and spinal cord. Without these protective coverings, the nerve cells cannot communicate properly with different parts of the body and the nerve cells eventually die leading to numerous neurological complications and disability.
This is the first time that GSK3888130B will be given to humans. So far it has only been tested on animals and in the laboratory. The study drug works by blocking the activation of the immune cells (white blood cells) that damage and attack the myelin sheaths in patients with MS. As a result, the damage to the nerve cells should be reduced.
Males, and females who are unable to have children, aged between 18 and 55 years will be invited to take part in this study and placed in 1 of 7 cohorts. Participants will be asked to come to GSK’s Clinical Unit Cambridge (CUC) for a short inpatient stay (up to 8 nights), followed by a number of outpatient visits.
Participants will receive a single dose of GSK3888130B via injection into a vein in the arm using a drip or injection just under the skin. Participants will be observed for any important side effects and will be assessed to determine the safety of the drug, and how the body handles the drug.
Taking part in the study will have no direct benefit to participants, but they will be helping GSK to develop a new drug for MS for which there is currently an unmet medical need for the treatment of disability progression.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
22/SC/0279
Date of REC Opinion
7 Oct 2021
REC opinion
Further Information Favourable Opinion