Safety, PK and PD of UCB5857 as SD and MD in healthy subjects
Research type
Research Study
Full title
A randomized, investigator-subject-blind, placebo-controlled, combined single & multiple ascending dose study to evaluate safety/tolerability, pharmacokinetic and pharmacodynamics profile of UCB5857 in healthy subjects.
IRAS ID
158990
Contact name
Annelize Koch
Contact email
Sponsor organisation
UCB Celltech, UK Registered Branch of UCB Pharma SA
Eudract number
2014-002361-30
Research summary
The new medicine being tested in this study is a compound called UCB5857. It is hoped that UCB5857 will be helpful in treating patients with immune-inflammatory diseases such as Rheumatoid arthritis, Lupus and Psoriasis.
An immune-inflammatory disease is caused, or triggered by, abnormalities of the normal immune response. The immune response is how the body recognises and defends itself against bacteria, viruses and substances that appear foreign and are harmful to your health.
The study will recruit male and female healthy subjects, between the ages of 18 and 55 years (inclusive). A total of 36 subjects will take part in the study.
This study will be performed at the PAREXEL Early Phase Clinical Unit (London), Northwick Park Hospital, Harrow, UK.
The main purpose of the study is to see how safe and how well tolerated UCB5857 is when given as single oral doses and as multiple oral doses in healthy subjects.
The study will also investigate how UCB5857 is taken up, metabolised (chemically broken down), distributed through the body and excreted as well. A further aim is to see how UCB5857 effects basophil degranulation when given as single oral doses and as multiple oral doses in healthy subjects. Basophil degranulation is a test used in the diagnosis of allergies including drug hypersensitivity – the basophils (a type of white blood cell that is activated during the immune response) are stimulated / irritated to release some of their content and during the study the test is repeated to check whether these cells are less sensitive to the stimulation or release less of their content.
Vital signs, safety ECG measurements, safety laboratory assessments, adverse events and concomitant medications will be monitored throughout the entire investigational period. Blood samples for pharmacokinetic and basophil degranulation analysis will be collected.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
14/SC/1035
Date of REC Opinion
18 Jul 2014
REC opinion
Further Information Favourable Opinion