NCT06937411已完成1 期
A Phase I, Randomized, Double-Blinded, Placebo-Controlled, 2-Part Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Ascending and Multiple Ascending Doses of DC-853 in Healthy Participants
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Part 1
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 participants.
Participation could last up to 7 weeks
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants must be able to understand and comply with the requirements of the study, as judged by the Investigator.
- •Participants must have a body mass index (BMI) ≥ 18 and ≤ 35 kilograms per meter squared (kg/m2).
排除标准
- •History or presence of any clinically relevant acute or chronic medical or psychiatric condition that could interfere with the participant's safety during the clinical study or expose the participant to undue risk as judged by the Investigator.
- •Malignancy within the past 5 years of screening with the exception of in situ removal of basal cell carcinoma, resected benign colonic polyps, or adequately treated cervix carcinoma in-situ.
- •Planned major surgery within duration of the study or the 30 days following study completion.
- •Females who are pregnant, breast feeding, lactating or plan to be pregnant during the study period or 90 days after.
- •History of any drug and/or alcohol abuse in the past 2 years prior to screening.
研究组 & 干预措施
LY4100511 (DC-853) Part 1
Experimental
Single doses of LY4100511 (DC-853) administered orally.
干预措施: LY4100511 (Drug)
LY4100511 (DC-853) Part 2
Experimental
Multiple doses of LY4100511 (DC-853) administered orally.
干预措施: LY4100511 (Drug)
结局指标
主要结局
Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Part 1
时间窗: Baseline up to 6 Days
Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Part 2
时间窗: Baseline up to 7 Days
次要结局
未报告次要终点
研究者
研究点 (1)
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