Bioavailability & tolerability of Bimekizumab in healthy subjects
Research type
Research Study
Full title
An open label, parallel group, single dose study to evaluate the relative bioavailability and tolerability of 160 mg subcutaneous Bimekizumab in healthy subjects
IRAS ID
199873
Contact name
Muna Albayaty
Contact email
Sponsor organisation
UCB Celltech
Eudract number
2015-005331-40
Duration of Study in the UK
0 years, 5 months, 29 days
Research summary
This is NOT First in Man study. The new medicine tested in this study is a compound called Bimekizumab (UCB4940), referred to as study drug throughout this document. It is hoped that the study drug will be helpful with autoimmune disorders and inflammatory diseases. 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 human health. Immune inflammatory diseases include rheumatoid arthritis or psoriasis. This study will recruit healthy males or females between the ages of 18 and 65 years. A total of 12 participants will take part in the study. This study will be performed at the PAREXEL Early Phase Clinical Unit (London), Northwick Park Hospital, Harrow, UK. In this study, two different formulations (Formulation A and Formulation B) of the study drug will be compared to determine if the formulations are similar in the way the study drug is absorbed, metabolised (broken down), and excreted by the body. The study will also look to see if the drug is safe and well tolerated. Blood tests may also be performed to assess the response of the body to the study drug, such as if body will produced a natural defense (antibodies) against the study drug (protein named anti the study drug antibody).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 analysis will be collected.
REC name
London - Harrow Research Ethics Committee
REC reference
16/LO/0211
Date of REC Opinion
3 Mar 2016
REC opinion
Further Information Favourable Opinion