BEN8744 - First doses in humans
Research type
Research Study
Full title
A randomised, double-blind, placebo-controlled, phase 1 first-in-human study to investigate the safety, tolerability, pharmacokinetics and food effect of single- and multiple-ascending doses of BEN8744 in healthy subjects
IRAS ID
1006884
Contact name
Adeola Adenuga
Contact email
Sponsor organisation
BenevolentAI Cambridge Ltd
Eudract number
2022-003721-22
ISRCTN Number
ISRCTN57043417
Clinicaltrials.gov Identifier
Research summary
BEN8744 (the study medicine) is an experimental new medicine for treating inflammatory bowel diseases such as Ulcerative Colitis (UC). UC patients have problems with their immune system which causes their intestines to become inflamed, leading to symptoms such as frequent diarrhoea, stomach aches, and incontinence (difficulty controlling when they go to the toilet).\n\nWe hope BEN8744 will work by blocking the activity of an enzyme (a substance in the body that breaks down other substances) called PDE10A that’s involved in UC. We think BEN8744 will be safer and more effective than current treatments for UC, which aren’t very reliable, work too slowly, or cause bad side effects. \n\nWe’ll test single and repeated doses of BEN8744 or placebo (a dummy medicine that looks the same as the study medicine but has no active ingredient) by mouth. BEN8744 has never been given to humans before, so we’ll start with a small dose and increase the dose as the study progresses. We aim to find out its side effects and blood levels when taken by mouth and whether food affects the blood levels.\n\nThis is a 3-part study (Parts A, B and C) in up to 108 healthy people, aged 18-65.\n\nIn Part A, we’ll give up to 64 participants single doses of BEN8744 or placebo. They’ll take about 2 weeks to finish the study, stay on the ward for 4 nights and 5 days in a row and make 2 outpatient visits.\n\nIn Part B, we’ll give up to 12 participants single doses of BEN8744 with and without food. They’ll take up to 3 weeks to finish the study, stay on the ward for 4 nights and 5 days in a row on 2 occasions, and make 2 outpatient visits.\n\nIn Part C, we’ll give up to 32 participants repeat doses of the BEN8744 or placebo for 14 days. They’ll take about 4 weeks to complete the study, stay on the ward for 17 nights and 18 days in a row and make 2 outpatient visits.\n\nA pharmaceutical company, BenevolentAI Cambridge Limited, is funding the study, which will take place in 1 centre in London.
REC name
North East - York Research Ethics Committee
REC reference
23/NE/0080
Date of REC Opinion
4 Jul 2023
REC opinion
Further Information Favourable Opinion