Conditions: Kidney Failure, Chronic
Keywords: Renal dialysis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 64
Healthy volunteers: yes

Brief summary:
The purpose of this study is to look at the tolerability and safety of LY3113593. Study doctors will see how safe it is and whether it produces side effects following a single injection into a vein or under the skin in healthy participants (Part A) and participants with chronic kidney disease treated with hemodialysis (Part B). The study will also measure how much of the study drug gets into the blood stream, how long it takes the body to get rid of the study drug and what effects the study drug has on the body.

This is the first time that this study drug is being given to participants. This study is for research purposes only and is not intended to treat any medical condition. For each participant, the study will last about 85 days, not including screening. Screening is required within 28 days prior to the start of the study.

Detailed description:

Arms:
arm 1: Single dose of LY3113593 administered intravenous (IV) at a minimum of six dose levels arm 2: Single dose of placebo matching LY3113593 administered IV arm 3: Single dose of LY3113593 administered subcutaneous (SC) arm 4: Single dose of placebo matching LY3113593 administered SC arm 5: Single dose of LY3113593 administered IV arm 6: Single dose of placebo matching LY3113593 administered IV

Interventions: intervention 1: LY3113593 intervention 2: LY3113593 intervention 3: Placebo intervention 4: Placebo
Intervention descriptions: intervention 1: Administered IV intervention 2: Administered SC intervention 3: Administered IV intervention 4: Administered SC

Protocol document: