LY3074828- SC and IV Bioavailability in Healthy Volunteers
Research type
Research Study
Full title
An Assessment of the Absolute and Relative Bioavailability of Subcutaneous Doses of LY3074828 when Coadministered with LY9999QS to Healthy Subjects
IRAS ID
225174
Contact name
Sunu Valasseri
Contact email
Sponsor organisation
Eli Lilly and Company
Eudract number
2017-001242-10
Clinicaltrials.gov Identifier
17-NE-0073,
Duration of Study in the UK
0 years, 5 months, 30 days
Research summary
LY3074828 is an experimental drug that is being investigated by the sponsor.The Study Drug is being developed with the aim of helping people with autoimmune and inflammatory diseases in the future, such as ulcerative colitis and Crohn’s disease.LY3074828 neutralises a protein in the body known as IL-23, which is associated with the development of many of these conditions. This drug has been investigated in previous studies.
LY9999QS is a protein called hyaluronidase, which is already marketed, and is known to help the administration of other drugs when they are given together as part of a subcutaneous (SC) injection (under the skin into the fatty tissue), meaning a larger volume may be administered and absorption may be improved.
This study will assess how much of the study drug is absorbed into the bloodstream when administered by SC injection with hyaluronidase(known as LY900021 in combination), compared to the study drug administered alone as an intravenous (IV) injection (straight into the vein). This is the first time the study drug and hyaluronidase will be coadministered, therefore it is essential to know how safe and well tolerated they are when given together.
There will be four different treatments assessed. Treatment 1 is a single dose of 1200mg IV LY3074828, treatments 2 and 3 are single SC doses of LY900021 (250mg and 1000mg respectively). Safety data collected up to Day 15 will be reviewed to determine if data supports a decision to dose with the 4th treatment, a single dose of 2400mg SC LY900021.
Up to 72 healthy participants will be enrolled in this Study. Each subject will receive one treatment only, with the aim of 16 people completing the study in each treatment group.The total duration of trial participation for each subject (screening to the follow up visit) is anticipated to be approximately 17 weeks.REC name
North East - York Research Ethics Committee
REC reference
17/NE/0073
Date of REC Opinion
22 Jun 2017
REC opinion
Further Information Favourable Opinion