A Placebo-controlled, Phase 1, Participant- and Investigator-blinded, Single- and Multiple- Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of LY4100511 (DC-853) in Healthy Asian and Non-Asian Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Number of participants with one or more Treatment Emergent Adverse Event(s) (TEAEs) and Serious Adverse Event(s) (SAEs)
研究概览
简要总结
The main purpose of this study is to assess the safety and tolerability of LY4100511 (DC-853) after single and multiple dose administrations in healthy asian participants and non-Asian participants. Part A consists of 2 groups and Part B, C, and D include optional groups.
详细描述
Part B and C added per protocol amendment (May 2024) Added Part B to explore higher dose levels and Part C to explore effects of food. Part D added per protocol amendment (June 2024) to explore higher multiple doses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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
- •Male and female participants who are overtly healthy as determined by medical history, vital signs, and physical examination.
- •Participants of Japanese, Chinese, and Non-Asian ethnicities
- •Have a body mass index within the range of 18.0 to 32 kilograms per square meter (kg/m²). For healthy Japanese participants, have a body mass index of 18.0 to 28.0 kg/m²
- •Have venous access sufficient to allow for blood sampling
- •Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
排除标准
- •Have a current or recent acute, active infection
- •Had any surgical procedure within 12 weeks prior to study
- •Are immunocompromised
- •Have presence of significant uncontrolled cerebro-cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neurologic or neuropsychiatric disorders or abnormal laboratory values
- •Are currently enrolled in a clinical study involving any experimental antibody or biologic therapy within the previous 6 months, or any other experimental therapy within 30 days before the first dose of the study intervention or during the study
研究组 & 干预措施
LY4100511 (DC-853) Part A Fasted
Single and multiple doses of LY4100511 (DC-853) administered orally.
干预措施: LY4100511 (DC-853) (Drug)
LY4100511 (DC-853) Part B
Single and multiple higher doses of LY4100511 (DC-853) administered orally.
干预措施: LY4100511 (DC-853) (Drug)
LY4100511 (DC-853) Part C (Open Label)
Single dose of LY4100511 (DC-853) administered orally in fed and fasted states.
干预措施: LY4100511 (DC-853) (Drug)
LY4100511 (DC-853) Part D
Multiple higher doses of LY4100511 (DC-853) administered orally.
干预措施: LY4100511 (DC-853) (Drug)
Placebo
Placebo administered orally.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of participants with one or more Treatment Emergent Adverse Event(s) (TEAEs) and Serious Adverse Event(s) (SAEs)
时间窗: Baseline up to 47 days
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
- Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY4100511 (DC-853)(Predose up to 47 days)
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4100511 (DC-853)(Predose up to 47 days)