Single-Dose Study to Assess Bioavailability of LY3074828

  • Research type

    Research Study

  • Full title

    A Phase 1, Single-Dose Study to Assess the Relative Bioavailability, Absolute Bioavailability, and Tolerability of LY3074828 Formulations in Healthy Subjects

  • IRAS ID

    217643

  • Contact name

    Jim Bush

  • Contact email

    jim.bush@covance.com

  • Sponsor organisation

    Eli Lilly and Company

  • Eudract number

    2016-003584-18

  • Duration of Study in the UK

    0 years, 4 months, 14 days

  • Research summary

    The Study Drug (LY3074828) is an experimental drug that is being developed by the sponsor, 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.

    In this study, 2 different formulations of LY3074828 will be studied: the current (Reference) formulation that has been used in previous studies and a new (Test) formulation that is proposed for later studies The Test formulation is being manufactured in a different way and will be supplied already mixed as a solution. The Reference formulation will be supplied as a freeze dried powder, and it has some different ingredients to the formulation (reference) that has been tested in ongoing clinical trials. In humans single doses of up to 1200mg IV of the Reference formulation have been administered, with few adverse reactions. This is the first time the Test formulation will be administered in humans.

    There will be four different treatments of LY3074828 being assessed in this Study all at a dose level of 250mg: the reference formulation as 3 separate subcutaneous (SC) injections (under the skin into the fatty tissue), the Test formulation as 2 separate SC injections, the Test formulation as 1 SC injection and the Test formulation as an intravenous (IV) infusion (straight into the vein). Up to seventy-two 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 (from screening through to the follow up visit) is anticipated to be approximately 19 weeks.

  • REC name

    North East - York Research Ethics Committee

  • REC reference

    17/NE/0013

  • Date of REC Opinion

    14 Mar 2017

  • REC opinion

    Further Information Favourable Opinion