A Multiple-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3113593 in Patients Receiving Hemodialysis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 5
- 主要终点
- Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
研究概览
简要总结
This study is not intended to treat anemia of chronic kidney disease but to determine the safety of the study drug, LY3113593.
The study will also evaluate how much of the study drug gets into the blood stream, how long it takes the body to remove the study drug, and what effect the study drug has on the body.
The study consists of up to three parts. Participants may only enroll in one part. Participants will receive up to four injections of LY3113593 or placebo into a vein. The study will last up to about 26 weeks including screening and follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
盲法说明
single-blind participant only
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Receiving hemodialysis regularly (at least 3 times per week) for at least 4 months
- •Have a hemoglobin value (taken prior to dialysis, if taken on a dialysis day) greater than or equal to 9.5 grams per deciliter (g/dL) and less than or equal to 11.0 g/dL at screening
- •Have been receiving erythropoiesis stimulating agent (ESA) injections for at least 4 weeks and are willing to stop the injections for approximately 8 weeks
排除标准
- •Have another health condition that may put the participant at risk or that the study doctor feels would make the participant unsuitable for the study
- •Currently taking part in another study
- •Have recently (within 30 days) completed a study or have previously taken part in this study
研究组 & 干预措施
LY3113593
Escalating doses of LY3113593 administered by intravenous (IV) infusion once every 4 weeks (Q4W) on (Day 1 and 29) in part A.
干预措施: LY3113593 (Drug)
Placebo
0.9% saline, administered by intravenous (IV) infusion once Q4W (Day 1 and 29) in part A.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
时间窗: Baseline through Day 29
A summary of other non-serious adverse events (AEs) and all serious adverse events, regardless of causality, is located in the reported adverse events section.
次要结局
- Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY3113593(Predose; 0.5, 4 hours post-dose)
- PK: Area Under the Concentration Versus Time (AUCτ)(Predose; 0.5, 4 hours post-dose)
- Pharmacodynamics (PD): Change From Baseline to Week 8 in Hemoglobin (Hb)(Predose; 0.5, 4 hours post-dose)
- Number of Participants With Anti-LY3113593 Antibodies Detection(Day 1: Predose; Day 15, 29, 57, 85 and 113)