Safety, blood levels and effects of UCB0107 in Japanese volunteers
Research type
Research Study
Full title
A single-center, investigator-blind, subject-blind, randomized, placebo-controlled study to evaluate safety and tolerability and pharmacokinetics of single doses of UCB0107 in healthy Japanese subjects (HMR code: 17-019)
IRAS ID
245886
Contact name
Denisa Wilkes
Contact email
Sponsor organisation
UCB Biopharma SPRL
Eudract number
2018-000475-32
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
The study medicine (UCB0107) is an experimental new medicine for treating a group of brain disorders called ‘tauopathies’, which includes Alzheimer’s disease, progressive supranuclear palsy (PSP), and Pick’s disease. \n\n‘Tau’ is a protein found in the brains of healthy people. In people with tauopathies, the body makes an abnormal form of tau that clumps together in the brain cells, and prevents the cells from working properly. Once abnormal tau has formed in the brain, it can spread to other brain cells, which causes the disease to get worse over time. \n\nThe study medicine contains a protein called a ‘monoclonal antibody’, which is made specifically for use in humans (antibodies are proteins made by the immune system in response to a foreign substance). We hope the study medicine will stop tauopathies from getting worse, by binding to abnormal tau so it can’t spread to other cells.\nIf this and future studies are successful, the study medicine would be a useful treatment for patients in many countries, including Japan. But first, we need to test the drug in healthy Japanese people, so that we can compare the results with those from other ethnic groups. \n\nWe’ll give up to 24 healthy Japanese participants, aged 20-75, a single dose of the study medicine, by slow injection into a vein, to find out its blood levels and any side effects. We’ll also investigate whether the body reacts to UCB0107; in particular, whether the body makes antibodies against it. \n\nParticipants will take up to 24 weeks to finish the study, have 2 screening visits, 1 of which includes an MRI (magnetic resonance imaging) scan, stay on the ward for 5 nights, and have up to 7 outpatient visits.\n \nA pharmaceutical company (UCB) is funding the study.\n\nThe study will take place at 1 centre in London.\n
REC name
HSC REC B
REC reference
18/NI/0078
Date of REC Opinion
17 May 2018
REC opinion
Favourable Opinion