Study of UTTR1147A in Healthy Volunteers & Ulcerative Colitis Patients
Research type
Research Study
Full title
An Observer-Blinded, Placebo-Controlled, Multible-Ascending, Dose-Escalation Study To Explore the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of repeat Intravenous Administrations UTTR1147A in healthy Volunteers and Patients with Ulcerative Colitis
IRAS ID
201944
Contact name
John Mansfield
Contact email
Sponsor organisation
Genentech
Eudract number
2015-002512-32
Duration of Study in the UK
0 years, 10 months, 16 days
Research summary
Ulcerative Colitis (UC) is a chronic inflammatory condition of the colon. UC is characterised by ulceration of the lining of the bowels, bloody diarrhoea, and abdominal pain, which may be complicated by severe bloody diarrhoea and toxic megacolon requiring removal of the entire colon. UC occurs in genetically susceptible individuals as a result of an exaggerated immune response to microbiota and environmental triggers in the colon.
Current treatments for moderate to severe UC rely on corticosteroid and other immuno-suppressants, such as anti-tumour necrosis factor (TNF) and anti-integrin therapy. The aim for newer therapies is to modify the course of the disease with a view to decreasing dependence on corticosteroids and the probability of progression to surgery, without significantly compromising patients’ immune system.
UTTR1147A is an investigational product being developed by Genentech Inc., which will try to increase the activity of a non-immunosuppressive cytokine called Interleukin-22 (IL-22). This cytokine plays a critical role in the bowel’s defense mechanisms against harmful micro-organisms and can also help stimulate healing of the bowel. As such, UTTR1147A is being developed to treat UC and other inflammatory bowel disorders.
This study will evaluate the safety, pharmacokinetics, and pharmacodynamics of repeat doses of UTTR1147A in healthy volunteers and patients with UC. The healthy volunteer cohorts of this study will be performed at a single site in Germany, and the first HV cohort will be conducted prior to opening recruitment for the UC patients. Procedures in this study include physical examinations, body measurements, blood collection, urine and stool samples, electrocardiograms, flexible sigmoidoscopies and/or colonoscopies with tissue biopsies and photographic skin assessments.REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
16/NE/0069
Date of REC Opinion
8 Apr 2016
REC opinion
Further Information Favourable Opinion