A Single-ascending and Multiple-ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LY4226695 in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 148
- 试验地点
- 2
- 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
The main purpose of this study is to assess how well LY4226695 is tolerated and what side effects may occur in healthy participants. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. For each participant in Parts A & D, the study will last about 64 days and will include a stay in the Clinical Research Unit (CRU) lasting at most 7 days. For each participant in Parts B & C, the study will last about 92 days and will include 5 stays in the CRU with each visit lasting at most 7 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
- 22 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Have a screening body mass index (BMI) in the range of 18.5 to 35 kilograms per square meter (kg/m²), inclusive, with no significant weight gain or loss in the past 3 months prior to screening.
- •Individuals assigned male at birth must agree to adhere to contraception restrictions and individuals assigned female at birth must not be of childbearing potential.
- •Part B Chinese participants:
- •To qualify as a Chinese participant for the purpose of this study, all the participants' biological grandparents must be Chinese and born in China.
- •Part C Japanese participants:
- •To qualify as a Japanese participant for the purpose of this study, all the participants' biological grandparents must be Japanese and born in Japan.
排除标准
- •Have a history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders.
- •Have known or ongoing psychiatric disorders.
- •Have a history of deep vein thrombosis of the leg or repeated episodes of deep leg vein thrombosis in first-degree relatives (parents, siblings, or children).
- •Have a history of fracture within 6 months prior to screening.
- •Have a history of fainting.
- •Regularly use known drugs of abuse or with positive drug results.
- •Have alcohol intake that exceeds recommended average weekly alcohol consumption limits per local regulation.
研究组 & 干预措施
LY4226695 Part C
Participants will receive LY4226695 or placebo administered SC
干预措施: Placebo (Drug)
LY4226695 Part A
Participants will receive LY4226695 or placebo administered subcutaneously (SC)
干预措施: LY4226695 (Drug)
LY4226695 Part A
Participants will receive LY4226695 or placebo administered subcutaneously (SC)
干预措施: Placebo (Drug)
LY4226695 Part B
Participants will receive LY4226695 or placebo administered SC
干预措施: LY4226695 (Drug)
LY4226695 Part B
Participants will receive LY4226695 or placebo administered SC
干预措施: Placebo (Drug)
LY4226695 Part C
Participants will receive LY4226695 or placebo administered SC
干预措施: LY4226695 (Drug)
LY4226695 Part D
Participants will receive LY4226695 administered intravenously (IV)
干预措施: LY4226695 (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 57
次要结局
- Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY4226695(Baseline through Day 57)
- PK: Maximum Concentration (Cmax) of LY4226695(Baseline through Day 57)