A Phase 1, Randomized, Participant- and Investigator-Blind, Placebo-Controlled, Single- and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3541860 in Healthy Japanese and Non-Japanese Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
研究概览
简要总结
The main purpose of this study is to evaluate the safety and tolerability of LY3541860 in healthy Japanese and non-Japanese participants. The study will also assess how fast LY3541860 gets into the blood stream and how long it takes the body to remove it. The study is open to healthy participants. The study will last up to approximately 113 days.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Are male or female not of childbearing potential
- •Have a body weight between 18 and 32 kilograms per square meter (kg/m²) and a body weight ≥ 50 kilograms (kg)
- •Have veins suitable for blood sampling
排除标准
- •Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
- •Have active or latent TB
- •Have had breast cancer within the past 10 years or had lymphoma, leukemia, or any malignancy within the past 5 years
- •Show clinical evidence of syphilis, HIV, hepatitis C, or hepatitis B, and/or test positive
- •Have received treatment with biologic agents (such as monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing.
- •Have previously completed a clinical trial investigating any other molecule targeting CD19, CD20 or have previously discontinued from this study after receiving LY3541860
- •Are currently participating in or completed a clinical trial within the last 30 days
- •Have received a vaccine containing a live (attenuated) virus within 28 days of screening or intend to receive during the course of the study.
研究组 & 干预措施
LY3541860 (Part A)
Single doses of LY3541860 administered intravenously (IV) or subcutaneously (SC).
干预措施: LY3541860 (Drug)
LY3541860 (Part B)
Multiple doses of LY3541860 administered either IV or SC.
干预措施: LY3541860 (Drug)
Placebo (Part A)
Single doses of Placebo administered either IV or SC.
干预措施: Placebo (Drug)
Placebo (Part B)
Multiple doses of Placebo administered either IV or SC.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
时间窗: Baseline through Day 113
A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
次要结局
- PK: Area Under the Concentration Versus Time Curve (AUC) of LY3541860(Predose on Day 1 through Day 113)
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3541860(Predose on Day 1 through Day 113)