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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
64
Administered IV
Administered SC
Administered IV
Administered SC
Parexel Early Phase Unit at Glendale
Glendale, California, United States
Orlando Clinical Research Center
Orlando, Florida, United States
Davita Clinical Research
Minneapolis, Minnesota, United States
Number of Participants With One or More Serious Adverse Event (s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
The number of participants with 1 or more SAEs assessed as related to the study drug and is summarized cumulatively. A serious adverse event is defined as an event that results in death, initial or prolonged hospitalization, is life-threatening, leads to persistent or significant disability/incapacity, is associated with congenital anomaly/birth defect, or is considered significant by the investigator for any other reason. A summary of all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Time frame: Baseline through end of study (Day 85)
Pharmacokinetics: Maximum Concentration (Cmax) of LY3113593
Time frame: Day 1: pre-dose, 30 minutes, 2 hours, 4 hours, 12 hours; Days 2, 3, 5, 8, 15, 22, 29, 43, 57, 71, and 85
Pharmacokinetics: Area Under the Concentration Curve to Infinity (AUC (0-∞)) of LY3113593
Time frame: Day 1: pre-dose, 30 minutes, 2 hours, 4 hours, 12 hours; Days 2, 3, 5, 8, 15, 22, 29, 43, 57, 71, and 85
Pharmacokinetics: Absolute Bioavailability of LY3113593 SC Versus IV Based on AUC Ratios
Time frame: Day 1: pre-dose, 30 minutes, 2 hours, 4 hours, 12 hours; Days 2, 3, 5, 8, 15, 22, 29, 43, 57, 71, and 85
Pharmacodynamics: Maximum Change From Baseline in Iron Parameter Profile of LY3113593
Time frame: Baseline, Day 85
Pharmacodynamics: Maximum Absolute Change From Baseline in TSat Parameter Profile of LY3113593
Time frame: Baseline, Day 85
Pharmacodynamics: Maximum Change From Baseline in Hemoglobin (Hb) Parameter Profile of LY3113593
Time frame: Baseline, Day 85
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