Safety and blood levels of SAN711 (HMR 21-005)
Research type
Research Study
Full title
A phase 1 study to assess the safety and tolerability of single and multiple ascending doses of SAN711 in healthy participants and to Determine GABAA Receptor Occupancy using Positron-emission Tomography (PET) (HMR code: 21-005)
IRAS ID
298270
Contact name
Rudolf Baumgartner
Contact email
Sponsor organisation
Saniona A/S
Eudract number
2021-001272-42
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Summary of Research
SAN711 (the study medicine) is an experimental medicine for treating pain caused by damage to nerves (neuropathic pain). The damaged nerves send pain messages to the brain when doing everyday activities that wouldn’t normally cause pain, such as touching a slightly cold object. We hope that the study medicine will work by increasing the activity of a substance on nerves (GABAA receptors), making the nerves less able to send pain messages to the brain.
This is a 3-part study in healthy volunteers, aged 18–65 years.
Parts 1 and 2: we aim to find out any side effects and measure blood levels of SAN711, when taken by mouth as single and repeated doses. Participants will take up to 7 weeks to finish the study, stay on the ward for up to 16 nights and make up to 2 telephone follow-up calls.
Part 3: we aim to find out how much SAN711 gets into the brain and attaches to GABAA receptors, blood levels of SAN711 and any side effects. Up to 8 participants will take a single dose of SAN711 and have 3 PET (positron emission tomography) scans. Before each PET, we’ll give an injection of a carbon-11-labelled radioactive tracer, which binds to GABAA receptors, whose presence in the brain will be followed by PET scan. Participants will be exposed to radiation levels similar to 3.5 years’ background radiation. Participants will take about 3 weeks to finish the study. They’ll have 2 screening visits, including having an MRI (magnetic resonance imaging) scan, 2 study sessions and 2 follow-up visits. They’ll stay on the ward for 1 night in Session 1, and 3 nights in Session 2.
A pharmaceutical company (Saniona A/S) is funding the study.
The study will take place at 1 research centre and 1 imaging centre in London.
REC name
London - Harrow Research Ethics Committee
REC reference
21/LO/0296
Date of REC Opinion
21 Apr 2021
REC opinion
Favourable Opinion