A Study of LY3361237 in Healthy Participants
赞助:
Eli Lilly and Company
合作者:
信息的提供 (责任方):
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| 追踪信息 | |||
|---|---|---|---|
| 首次提交日期 ICMJE | October 2, 2018 | ||
| 首次发布日期e ICMJE | October 4, 2018 | ||
| 最后更新发布日期 | October 4, 2018 | ||
| 预计研究开始日期 ICMJE | October 26, 2018 | ||
| 预计主要完成日期 | September 7, 2019 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration[ Time Frame: Baseline through Week 12 ] A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | A Study of LY3361237 in Healthy Participants | ||
| 正式标题 ICMJE | A Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3361237 in Healthy Subjects | ||
| 简要概况 | The purposes of this study are to determine: - The safety of LY3361237 and any side effects that might be associated with it. - How much LY3361237 gets into the blood stream and how long it takes the body to remove it in healthy participants. Participants will be admitted to the clinical research unit (CRU) for 4 overnight stays. The study will last about 12 weeks for each participant, not including screening. |
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| 详细说明 | |||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | Phase 1 | ||
| 研究设计 ICMJE | 分配: Randomized 干预模型: Parallel Assignment 干预模型描述: 盲法: Interventional 盲法描述: 主要目的: Basic Science |
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| 适用条件 ICMJE | |||
| 干预项目 ICMJE |
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| 研究工具 |
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| 招募信息 | |||
| 招募状态 ICMJE | Not yet recruiting | ||
| 预计入组 ICMJE |
85 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | September 7, 2019 | ||
| 预计主要完成日期 | September 7, 2019 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: - Healthy males or females, as determined by medical history and physical examination. - To qualify as Japanese for this study, the participant, the participant's biological parents, and all of the participant's biological grandparents must be of exclusive Japanese descent and born in Japan. - Between 18 (20 for Japanese participants) and 65 years of age. - Have a body mass index of 18.0 to 32.0 kilograms per meter squared, inclusive, and a minimum body weight of 45.0 kilograms. Exclusion Criteria: - Show evidence of active or latent tuberculosis (TB), as documented by medical history and examination, chest x-ray and TB testing - Are immunocompromised - Have evidence of chronic viral infection have received live vaccine(s) (including attenuated live vaccines) within 28 days of screening or intend to receive during the study (non-live or inactivated vaccinations are allowed). Bacillus Calmette-Guérin (BCG) vaccine must not have been administered within 12 months of screening - Have had lymphoma, leukemia, or any malignancy or pre-malignant condition within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years | ||
| 性别 |
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| 年龄 | 最小年龄：18 Years ，最大年龄：65 Years | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | United States | ||
| 管理信息 | 数据检测委员会 | No | |
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: Yes 研究涉及美国FDA监管的设备产品: No |
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| IPD 共享声明 |
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| 责任方 | ， | ||
| 研究赞助商 ICMJE | Eli Lilly and Company | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
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| PRS 账户 | |||
| 验证日期 | October 1, 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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