Safety, PK and PD of CBS001
Research type
Research Study
Full title
A double-blind, randomized, placebo-controlled, phase 1 study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of single- and multiple-ascending doses of intravenously administered anti-LIGHT monoclonal antibody CBS001 in healthy volunteers.
IRAS ID
1004650
Contact name
Colin Michael Perkins
Contact email
Sponsor organisation
Capella Bioscience Ltd, a Centessa Company
Eudract number
2021-006484-21
Clinicaltrials.gov Identifier
Research summary
The study medicine (CBS001) is an experimental treatment for long-term (chronic) conditions that involve inflammation, such as inflammatory bowel disease (IBD), and pulmonary fibrosis. Inflammation occurs when the body’s immune system sends out inflammatory cells and chemical messengers in response to an injury or infection. If the body sends out inflammatory cells when there is no infection or injury it may cause long-term inflammation. Over time, chronic inflammation can cause serious damage and scarring of body tissues and organs.
The study medicine contains a type of protein called a ‘monoclonal antibody’, which is made specifically for use in humans. It is hoped that the study medicine will reduce chronic inflammation by blocking a substance on inflammatory cells, called LIGHT.
This is a 2-part study (Parts A and B) in healthy volunteers, aged 18–65 years. We aim to find out any side effects of the study medicine, and its blood levels and effects on the body, when injected into a vein as single and repeated doses. It’s never been given to humans before, so we’ll start with a small dose, and increase the dose as the study progresses, if previous doses are shown to be safe.
In Part A, we’ll give single doses of the study medicine to up to 64 healthy volunteers (8 groups of 8 participants). Participants will take about 18 weeks to finish the study. They’ll make 5 outpatient visits and stay on the ward for 4 nights in a row.
In Part B, we’ll test repeated doses of the study medicine in up to 24 healthy volunteers (3 groups of 8 participants). Participants will take about 24 weeks to finish the study. They’ll make 9 outpatient visits and stay on the ward for 3 nights in a row on 3 occasions.
A pharmaceutical company called Capella Bioscience is funding the study
The study will take place at 1 centre in London.
REC name
North East - York Research Ethics Committee
REC reference
22/NE/0002
Date of REC Opinion
22 Mar 2022
REC opinion
Further Information Favourable Opinion