Safety, tolerability, PK & PD of UCB4019 as SAD in healthy subjects
Research type
Research Study
Full title
A Subject-Blind, Investigator-Blind, Randomized, Placebo-Controlled, First-In-Human Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of Single Ascending Subcutaneous Doses of UCB4019 in Healthy Subjects
IRAS ID
206828
Contact name
Muna Albayaty
Contact email
Sponsor organisation
UCB Biopharma
Eudract number
2016-000772-26
Duration of Study in the UK
0 years, 5 months, 0 days
Research summary
The new medicine tested in this study is a compound called UCB4019. It is hoped that UCB4019 will be helpful in treating patients with diseases of the immune system such as myasthenia, pemphigus vulgaris, neuromyelitis optica and Guillain-Barré Syndrome.
The purposes of this study are to:
•Determine how safe the study drug is and how well it is tolerated.
•How the study drug is taken up (absorbed subcutaneously under the skin), metabolised (chemically broken down), distributed through the body and excreted (removed from the body). This is called pharmacokinetics (PK) of a drug.
•Investigate the effect of the study drug on immunoglobulin G (which is a type of antibody) concentration in blood samples.This study will recruit healthy, male and female volunteers between the ages of 18 and 64 years (inclusive). A total of 32 subjects are planned to take part in the study.
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
South Central - Berkshire B Research Ethics Committee
REC reference
16/SC/0248
Date of REC Opinion
8 Jul 2016
REC opinion
Further Information Favourable Opinion