A study to examine LY3002815 in healthy subjects
Research type
Research Study
Full title
A Single Ascending Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of LY3002815 in Healthy Subjects
IRAS ID
223405
Contact name
Valasseri Sunu
Contact email
Sponsor organisation
Eli Lilly and Company
Eudract number
2016-004453-33
Clinicaltrials.gov Identifier
17/LO/0317, REC
Duration of Study in the UK
0 years, 5 months, 18 days
Research summary
The study drug is an investigational drug which is being developed by the sponsor with an aim to help people with Alzheimer’s disease in the future.
Alzheimer’s is an age-related disease that affects the nervous system and causes damage to parts of the brain that are responsible for memory and the ability to think and perform basic activities.
Alzheimer’s is an irreversible, progressive disease that is thought to be caused by a build up of protein deposits known as “amyloid plaques” in the brain.
There is currently no cure for Alzheimer’s but there is medication available that can help relieve some of the symptoms and slow down the progression of the disease. It is hoped that the study drug will reduce the build up of amyloid plaque deposits in the brain in patients with Alzheimer’s. It is also hoped that the study drug will slow the progression of the disease without causing troublesome side effects.
Up to 45 healthy male and female participants will be participating in this study. This study will be conducted at 1 site (our Unit) only.
The intention is to dose up to 4 cohorts (Cohort 1 to 4).
Cohorts 1 and 3 will each comprise of 8 participants of non Japanese origin only.
In Cohorts 2 and 4, the intention is to enrol 4 participants of first generation Japanese origin and 4 participants of non-Japanese origin.
The reason for specifying the inclusion of Japanese participants in Cohorts 2 and 4 is that this study will hopefully support further development of the study drug in Japanese patients.
The dose will be administered as a single intravenous infusion.
At the beginning of Cohort 1, one participant will receive the study drug and one will receive placebo. The safety data from these first 2 participants will be reviewed prior to dosing of the remaining 6 participants. Participants in subsequent cohorts will be dosed only after the safety data from the previous dose level has been reviewed.
The total duration of trial participation for each subject (from screening through to the last follow up visit) is anticipated to be approximately 4 months.REC name
London - Brent Research Ethics Committee
REC reference
17/LO/0317
Date of REC Opinion
2 May 2017
REC opinion
Further Information Favourable Opinion