VHsquared V56501
Research type
Research Study
Full title
A four part, Phase 1, first time in human, single centre study in healthy male subjects, patient volunteers with Crohn’s disease and in healthy patient volunteers with a terminal ileostomy.
IRAS ID
184795
Contact name
James Ritter
Contact email
Sponsor organisation
VHsquared Ltd
Eudract number
2015-002110-68
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 4 months, 1 days
Research summary
V565 is a modified antibody that blocks a mediator of inflammation called TNF, known to be produced excessively in Crohn’s disease (CD). TNF causes inflammation of the bowel, and blocking this underlies the therapeutic effect of TNF-antagonists in CD. Unlike licensed TNF antagonists V565 can be administered orally and is not generally absorbed into the circulation in experimental animals. This study examined for the first time in humans the safety, tolerability and the way the body handles (absorbs, distributes, breaks down and excretes) orally administered V565. The study was in four parts. Part 1 investigated single ascending oral doses in up to 38 healthy volunteers divided into 5 groups. Each group was dosed with an increased dose providing the drug was safe and well tolerated at the previous dose level. Part 2 investigated repeated doses in up to 10 healthy volunteers. Part 3 investigated a single dose in 6 otherwise healthy participants with a terminal ileostomy, a therapeutic procedure where small bowel (ileum) is diverted through the abdominal wall following surgical removal of the large bowel (colon). Part 4 investigated a single dose in a maximum of 8 patients with Crohn’s disease. In parts 1 and 2 of the study, participants were randomly allocated (as in tossing a coin) to V565 or placebo (dummy drug). Neither the investigators or the trial subjects knew whether the treatment is V565 or the placebo in any particular subject. Each subject had 3 visits: a screening visit, with informed consent and clinical assessment of eligibility; a residential period at Quintiles research unit for drug administration and clinical assessments; and a follow up visit.
REC name
HSC REC B
REC reference
15/NI/0136
Date of REC Opinion
30 Jul 2015
REC opinion
Further Information Favourable Opinion