SAD and MAD study in healthy and mild-to-moderate psoriatic subjects
Research type
Research Study
Full title
A randomised, double-blind, placebo-controlled, single and multiple ascending dose study evaluating the safety/tolerability, pharmacokinetic and pharmacodynamic effects of UCB5857 in healthy and mild-to-moderate psoriatic subjects.
IRAS ID
134429
Contact name
Annelize Koch
Contact email
Sponsor organisation
UCB Celltech, UK Registered Branch of UCB Pharma SA
Eudract number
2013-002323-42
ISRCTN Number
n/a
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 harmful to the body.
The study will recruit male and female healthy and mild-to-moderate psoriatic subjects, between the ages of 18 and 55 years (inclusive).
This study will be performed at the PAREXEL Early Phase Clinical Unit (London), Northwick Park Hospital, Harrow, UK.
The primary objective of this study is to investigate the safety and tolerability of UCB5857 when given as single oral doses in healthy subjects and as ascending multiple oral doses in healthy and mild-to-moderate psoriatic subjects.
The study will also investigate how the study drug is taken up, metabolised (chemically broken down), distributed through the body and excreted, as well as how the study drug effects basophil degranulation (the release of basophils, a type of white blood cell, from body cells) when given as single oral doses in healthy subjects and as ascending multiple oral doses in healthy and mild-to-moderate psoriatic subjects.
A further aim is to look at how the above described process is possibly altered by food by giving single oral doses of the study drug to healthy subjects in the presence and absence of meals.
Vital signs, safety ECG measurements, safety laboratory assessments, blood glucose levels, adverse events and concomitant medications will be monitored throughout the entire investigational period. Plasma samples for pharmacokinetic and pharmacodynamic (what UCB5857 does to the body) analysis will be collected and the effect of UCB5857 on plaque psoriasis will also be evaluated by various assesments, including skin biopsies.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
13/SC/0366
Date of REC Opinion
30 Jul 2013
REC opinion
Further Information Favourable Opinion