PET study of repeated ASN51 in healthy volunteers (HMR code 22-012)
Research type
Research Study
Full title
A phase 1, open-label, positron emission tomography study in healthy subjects to determine the relationship between plasma concentration and target occupancy of ASN51 following repeated oral doses.
IRAS ID
1006677
Contact name
Pearl Fang
Contact email
Sponsor organisation
Asceneuron S.A.
Clinicaltrials.gov Identifier
Research summary
The study medicine (ASN51) is an experimental treatment for Alzheimer’s disease (AD). People with AD have problems with their memory, judgement and understanding, and they may become confused and have mood swings. AD gets worse slowly and there’s no cure for it. Some medicines improve the symptoms of AD, but they don’t work for everyone, can cause troublesome side effects, and become less effective as the disease progresses.
We believe that AD is caused by the toxic build-up and clumping of a protein called ‘tau’ in the brain. A substance called OGA (O-linked-β-N-acetylglucosaminidase) changes tau in a way that causes it to build-up and clump. We hope that ASN51 will work by blocking the activity of OGA to reduce the build-up and clumping of tau in the brain.
We’ll test repeated doses of ASN51 in healthy men and women to find out its blood levels, side effects, and to measure how much ASN51 enters the brain and attaches (‘binds’) to OGA. To find out, we’ll use a type of brain scan called a PET (positron emission tomography) scan, which makes images of the brain. We’ll also aim to find out if ASN51 has an effect in certain cells of the immune system known as ‘peripheral blood mononuclear cells’ (or PBMCs’) and whether food changes the effect of ASN51 in PBMCs.
Eligible participants (12 healthy men and women, aged 25–55 years) will take 14 daily doses of ASN51. 8 of those participants will have 3 PET scans (“PET scan participants”) – the other 4 participants (“PBMC participants”) won’t have any PET scans. PET scan participants will also have an MRI (magnetic resonance imaging) scan at a separate screening visit, which uses a strong magnetic field to take pictures of the brain.
Participants will take about 8 weeks to finish the study. They’ll stay on the ward for 20 nights and make up to 3 outpatient visits.
A pharmaceutical company (Asceneuron S.A.) is funding the study.
The study will take place at 1 research centre and 1 imaging centre in London.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
22/LO/0814
Date of REC Opinion
26 Jan 2023
REC opinion
Further Information Favourable Opinion