LY3873862 – first doses in humans
Research type
Research Study
Full title
A Single Ascending and Multiple Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3873862 in Healthy Participants.
IRAS ID
1005792
Contact name
Jennifer Watson Curry
Contact email
Sponsor organisation
Eli Lilly and Company
Eudract number
2022-000500-36
Clinicaltrials.gov Identifier
Research summary
LY3873862 (the study medicine) is an experimental new medicine for treating amyotrophic lateral sclerosis (ALS). ALS is a rare but serious disease that causes nerve cells in the brain and spinal cord to gradually stop working over time. Currently, there is no cure for ALS, nor any effective treatment to stop the disease getting worse. We hope LY3873862 will work by blocking an enzyme (a substance that causes biological changes in the body) called SARM1, which is thought to be involved in nerve damage in ALS and other similar diseases.
This is a 2-part study (Parts A and B) in up to 102 healthy people, aged 18–65.
We’ll test single and repeated doses of LY3873862 to find out its side effects, blood levels and levels in the spinal fluid. We’ll also test whether food effects blood levels of LY3873862, and whether taking LY3873862 together with existing medicines affects the way the body handles each medicine.
LY3873862 has never been given to humans before, so, in each part, we’ll start with a small dose and increase the dose as the study progresses.
Participants will be screened within 4 weeks of their first dose.
In Part A, 6 groups of 8 participants will take single doses of LY3873862 or placebo. They’ll take 2 weeks to finish the study, stay on the ward for 4 days and 3 nights in a row and make 3 outpatient visits.
In Part B, 5 groups of 8–10 non-Japanese participants (Groups B1–B5) and 3 groups of 4 Japanese participants (Groups JP B1– B3) will take repeated doses of LY3873862 or placebo for 14 days. Participants in Group B4 will also take a single dose of 3 existing medicines on 2 days. Participants in Group B5 will also give a sample of spinal fluid.
Participants will take up to 4 weeks to finish the study. They’ll stay on the ward for up to 17 days and 16 nights in a row and make 4 outpatient visits.
A pharmaceutical company (Eli Lilly and Company) is funding the study. The study will take place at 1 centre in London.
REC name
HSC REC B
REC reference
22/NI/0095
Date of REC Opinion
13 Jul 2022
REC opinion
Further Information Favourable Opinion