A Study of LY3451838 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 1, 2018 | ||
| 首次发布日期e ICMJE | October 2, 2018 | ||
| 最后更新发布日期 | October 2, 2018 | ||
| 预计研究开始日期 ICMJE | December 2018 | ||
| 预计主要完成日期 | November 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 any Treatment Emergent Adverse Event[ Time Frame: Baseline through twenty weeks ] Serious and other non-serious adverse events will be reported in the Adverse Events Module Number of Participants with One or More Serious Adverse Events[ Time Frame: Baseline through twenty weeks ] Serious and other non-serious adverse events will be reported in the 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 LY3451838 in Healthy Participants | ||
| 正式标题 ICMJE | A Safety, Tolerability, and Pharmacokinetics Study of LY3451838 in Healthy Subjects | ||
| 简要概况 | The study has two parts. In Part A, single increasing doses of LY3451838 will be administered intravenously (into a vein). In Part B, a single dose of LY3451838 will be administered subcutaneously (just under the skin). |
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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 |
80 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | November 2019 | ||
| 预计主要完成日期 | November 2019 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: - Male participants must adhere to contraception restrictions - Female participants must be of non-childbearing potential due to: - Menopause: spontaneous amenorrhea for at least 12 months not induced by a medical condition such as anorexia nervosa and not taking medications that induced the amenorrhea (e.g., oral contraceptives, hormones, gonadotropin releasing hormone, anti-estrogens, selective estrogen receptor modulators, or chemotherapy) - Surgical sterilization - Have a body mass index of 18 to 32 kilograms per square meter (kg/m²) - Have clinical laboratory test results within normal reference range or with acceptable deviations - Have an estimated glomerular filtration rate greater than or equal to (≥) 60 milliliters per minute per 1.73 meters squared (mL/minute/1.73 m²) of body surface area - Have venous access sufficient to allow for blood sampling Exclusion Criteria: - Are currently enrolled in or discontinued from a clinical trial within the last 30 days, or have previously completed or withdrawn from this study - Have a history or presence of medical illness including, but not limited to, any cardiovascular, hepatic, respiratory, hematological, renal, endocrine, psychiatric or neurological disease, or any clinically significant laboratory abnormality - Have history of or presence of uncontrolled asthma, significant atopy, or significant rheumatological or autoimmune diseases - Have had lymphoma, leukemia, or any malignancy within the past 5 years, or breast cancer within the past 10 years (with some exceptions) - Have used, or intend to use some prescription or over the counter medications, including herbal medications within 14 days prior to dosing - Have an abnormality in the 12-lead electrocardiogram (ECG) or Fridericia's corrected QT (QTcF) - Show evidence of human immunodeficiency virus (HIV) and/or positive human HIV antibodies, hepatitis C and/or positive hepatitis C antibody, or hepatitis B and/or positive hepatitis B surface antigen - Have donated blood of more than 450 milliliters (mL) within the last 3 months - Are unwilling to stop alcohol consumption while resident in the Clinical Research Unit (CRU) - Have an average weekly alcohol intake that exceeds 21 units per week for males and 14 units per week for females (1 unit = 12 ounces (oz) or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits) - Current smoker of more than 10 cigarettes or equivalent per day and unable to stop smoking while in the CRU - Have an abnormal blood pressure - Have clinically significant proteinuria or hematuria - Positive findings for known drugs of abuse - Have received treatment with biologic agents within 3 months or 5 half-lives (whichever is longer) - Have clinically significant allergies, or intolerance to corticosteroids, or severe post treatment hypersensitivity reactions | ||
| 性别 |
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| 年龄 | 最小年龄：21 Years ，最大年龄：65 Years | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | |||
| 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: No 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 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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