NCT07566338招募中1 期
A Phase 1, Randomized, Placebo-Controlled, Investigator and Participant Blinded, Single Ascending Dose and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY4302814 in Healthy Participants
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 2
研究概览
简要总结
The main purpose of this study is to assess how well LY4302814 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, the study will last about 6 months and will include at least one overnight stay in the clinical research unit (CRU) lasting up to approximately 9 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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Are overtly healthy as determined by medical evaluation.
- •Have clinical laboratory test results within the normal range for the population or investigative site or with abnormalities deemed not clinically significant by the investigator.
- •Have a body weight of 45 kilograms (kg) or greater and body mass index within 18 to 32 kilogram per square meter (kg/m ²), inclusive.
- •Are individuals assigned female at birth (AFAB) and not of childbearing potential, and individuals assigned male at birth (AMAB). Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- •Adult participants in Singapore:
- •Are 21 years of age or older.
排除标准
- •Evidence or history of clinically significant conditions.
- •Have a 12-lead electrocardiogram (ECG) abnormality, that, in the opinion of the investigator, increases the risks associated with participating in the study or may confound ECG data analysis.
- •Show evidence of hepatitis B virus (HBV) infection with a positive hepatitis B surface antigen (HBsAg) or anti-hepatitis B core (HBc).
- •Show evidence of hepatitis C virus (HCV) infection, with positive anti-HCV.
- •Have human immunodeficiency virus (HIV) infection or positive HIV-1 and HIV-2 antibodies.
- •Have used or intend to use herbal, vitamin supplements, over-the-counter or prescription medication, within 14 days or 5 half-lives (whichever is longer) prior to dosing and during the study, unless, in the opinion of the investigator and sponsor, the medication will not interfere with the study.
- •Smoke more than 5 cigarettes a day, or the equivalent in nicotine-containing products, and/or are unable to abide by clinical research unit (CRU) smoking restrictions.
- •Have alcohol intake that exceeds recommended average weekly alcohol consumption limits per local regulation, or an amount deemed significant by the investigator.
研究组 & 干预措施
Placebo SC
Placebo Comparator
Placebo administered SC
干预措施: Placebo (Drug)
LY4302814 IV
Experimental
LY4302814 administered intravenously (IV)
干预措施: LY4302814 (Drug)
Placebo IV
Placebo Comparator
Placebo administered IV
干预措施: Placebo (Drug)
LY4302814 SC
Experimental
LY4302814 administered subcutaneously (SC)
干预措施: LY4302814 (Drug)
研究者
研究点 (2)
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