Study Investigating SC Injections of LY3074828 alone or with LY9999QS
Research type
Research Study
Full title
A Study to Investigate the Effects of Injection Volume, Injection Speed, and Drug Concentration on the Tolerability of Subcutaneous Injections of LY3074828 Alone or When Coadministered with LY9999QS, Compared to Placebo
IRAS ID
245900
Contact name
Lisa Husband
Contact email
Sponsor organisation
Eli Lilly and Company
Eudract number
2018-000773-68
Duration of Study in the UK
0 years, 7 months, 30 days
Research summary
The Study Drug (LY3074828) 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.\n\nLY9999QS 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 (a permeation enhancer). \n\nThis is a Phase 1 study conducted to determine acceptable injection volumes, injection flow rates, and drug concentrations for subcutaneous (SC) injections of LY3074828 in healthy subjects when compared to placebo in Part A. In Part B of this study, the addition of LY9999QS, a permeation enhancer, to the LY3074828 drug product may improve the tolerability of SC administration of larger volumes. \n\nUp to 60 subjects may be enrolled to ensure at least 48 subjects complete the trial (24 completers for Part A and 24 completers for Part B). \n\nIn Part A, each subject will participate in four periods in a crossover design. After randomization, subjects will receive study drugs by SC injection on the morning and afternoon of Day 1 of each Period. \n\nPart B is a 2-period crossover design. Subjects in Part B will receive 2 treatments in Period 1 (morning and afternoon) and 1 treatment in period 2 (morning only). \nThe total duration of trial participation for each subject (from screening through to the follow up visit) is anticipated to be approximately 16 weeks. Subjects will be followed up for 12 weeks from the first dose administered in Part A & B. \n\n\n
REC name
North East - York Research Ethics Committee
REC reference
18/NE/0133
Date of REC Opinion
20 Jul 2018
REC opinion
Further Information Favourable Opinion