Safety, tolerability, blood levels and side effects of Zampilimab
Research type
Research Study
Full title
A Randomized, Participant-Blind, Investigator-Blind, Placebo-Controlled Study Evaluating Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Intravenous Doses of Zampilimab in Healthy Participants
IRAS ID
1003473
Contact name
David Galloway
Contact email
Eudract number
2020-004411-26
Research summary
Research Summary
The study medicine (zampilimab) is an experimental treatment for the build-up of scar
tissue in the kidney (known as kidney fibrosis), which can stop the kidneys working
properly, and can lead to kidney failure. There is currently no licensed treatment for
kidney fibrosis.
The study medicine contains a large protein called a ‘monoclonal antibody’, which is
made specifically for use in humans. It is designed to attach (‘stick’) to and block the
activity of a particular protein (TG2), which plays a key role in the formation of scar
tissue.
We will give 16 healthy volunteers, aged 18–55, single doses of the study medicine by
slow infusion into a vein. We aim to find out the side effects and blood levels of
zampilimab, how it affects levels of TG2 in the blood, and whether the body makes
antibodies against it.
Participants will take up to 18 weeks to finish the study. They will stay on the ward for 5
nights, and make up to 7 outpatient visits .
A pharmaceutical company (UCB) is funding the study.
The study will take place at 1 centre in London.REC name
London - Hampstead Research Ethics Committee
REC reference
20/LO/1192
Date of REC Opinion
17 Dec 2020
REC opinion
Further Information Favourable Opinion