A study in HV to investigate a new drug for the treatment of fibrosis
Research type
Research Study
Full title
A subject-blind, investigator-blind, randomized, placebo-controlled, first in human study evaluating the safety/tolerability and pharmacokinetics of single ascending intravenous and subcutaneous doses of UCB7858 in healthy subjects
IRAS ID
207878
Contact name
Muna Albayaty
Contact email
Sponsor organisation
UCB Celltech
Eudract number
2016-001129-15
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 6 months, 6 days
Research summary
Before a new medicine can be approved for use in humans, it is necessary to confirm that it is safe and effective. This is done by carrying out research studies (or clinical studies) such as this one.\n\nThe new medicine tested in this study is a compound called UCB7858 (referred to as the “study drug“). The Sponsor UCB Biopharma SPRL is developing the study drug for treating fibrosis.\n\nThe main purpose of the study is to see how safe and tolerable the drug is when given as either single intravenous (IV) or subcutaneous (SC) doses in healthy subjects. The study will also investigate how the study drug is taken up, metabolized, distributed through the body and excreted, called pharmacokinetics (PK). A further aim is to look at the amount of unchanged study drug available in the blood after SC dosing.\n\nThis study will recruit healthy male and female subjects aged between 18 and 55 years of age inclusive. All subjects eligibility will be assessed based on inclusion and exclusion criteria. A total of 64 subjects will take part in the study.However, in the event that additional doses will need to be explored, 16 additional subjects may be enrolled, therefore potentially making a total of 80 subjects in this study.This is the first time the study drug will be given to humans.\n\nVital signs, safety electrocardiogram (ECG) measurements, safety laboratory measurements, adverse events, physical examinations and concomitant medications will be monitored throughout the entire investigational period.
REC name
London - Bloomsbury Research Ethics Committee
REC reference
16/LO/0946
Date of REC Opinion
24 Jun 2016
REC opinion
Further Information Favourable Opinion