Exploratory Study of V565 in Ulcerative Colitis Patient Volunteers
Research type
Research Study
Full title
An open-label exploratory study in patient volunteers with ulcerative colitis (UC), to investigate lamina propria presence and evidence of biological effect of the oral domain antibody V565
IRAS ID
221784
Contact name
Gareth Parkes
Contact email
Sponsor organisation
VHsquared Ltd
Eudract number
2016-003572-51
Duration of Study in the UK
0 years, 5 months, 1 days
Research summary
This is a 7 week study to recruit up to 6 patient volunteers with mild to moderate Ulcerative Colitis (UC) over at least 12 months. The primary purpose of the study is to assess the biological activity of V565 in the gut in subjects with active UC after 7 days oral administration of V565. In addition, safety and tolerability and levels of study drug in the blood, urine and faeces, and other biomarkers are being assessed.
Volunteers will be administered 3 x 185mg capsules of V565, 3 times a day during the treatment period. Prior to the 7-day treatment period, volunteers will enter a screening period of up to 28 days. Following treatment, volunteers will be followed-up for safety with a follow-up visit 14 days after the end of treatment. The first dose will be administered at the investigator’s site and then all remaining doses will be administered at home.
Prior to and at the end of treatment, volunteers will have a flexible sigmoidoscopy and have biopsies taken from the gut lining in the worst affected region of their colon (large intestine). Safety blood samples will be taken at all visits and exploratory blood samples taken prior to and at the end of treatment. Additionally, vital signs, physical exam findings, ECG scans, concomitant medications and adverse events will be used to assess the safety of the study drug.REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
17/EE/0057
Date of REC Opinion
28 Mar 2017
REC opinion
Further Information Favourable Opinion