Safety, blood levels and effects of rozanolixizumab v1
Research type
Research Study
Full title
A randomized, participant-blind, investigator-blind, placebo-controlled study comparing safety, tolerability, pharmacokinetics, and pharmacodynamics of single ascending subcutaneous doses of rozanolixizumab in Japanese and Caucasian healthy-volunteer study participants (18-024).
IRAS ID
259226
Contact name
Denisa Wilkes
Contact email
Sponsor organisation
UCB Biopharma SPRL
Eudract number
2018-004485-34
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
The study medicine (rozanolixizumab) is an experimental treatment for autoimmune diseases. Normally, the immune system defends the body from harmful substances (such as infections) by making proteins called antibodies – the antibodies stick to and destroy the harmful substances. But in patients with autoimmune diseases, the immune system makes antibodies that attack healthy parts of the body.
We hope the study medicine will be more effective, and have fewer side effects, than existing treatments for autoimmune diseases. It contains specially made proteins called ‘monoclonal antibodies’, which are made specifically for use in humans. The study medicine blocks a substance called FcRn, which we hope will reduce the blood levels of antibodies that cause certain autoimmune diseases.
If this and future studies are successful, the study medicine would be a useful treatment for patients in many countries, including Japan. First, we need to find out whether the blood levels, safety and effects of the study medicine vary among ethnic groups or not. So we’re doing this study in healthy Caucasian and Japanese people.
We’ll give 44 healthy men and women, aged 18–65, a single dose of the study medicine or dummy medicine by slow injection under the skin, to find out its blood levels and any side effects. We’ll also investigate whether the body reacts to the study medicine; in particular, whether the body makes antibodies against it.
We’ll screen participants during the 4 weeks before they start the study. Participants will take up to 8 weeks to finish the study. They’ll stay on the ward for 5 nights and make up to 9 outpatient visits.
A pharmaceutical company (UCB) is funding the study.
The study will take place at 1 centre in London.
REC name
HSC REC A
REC reference
19/NI/0004
Date of REC Opinion
25 Feb 2019
REC opinion
Further Information Favourable Opinion