A Safety, Tolerability, and Pharmacokinetics Study of LY3451838 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Number of Participants With Any Treatment Emergent Adverse Event
研究概览
简要总结
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).
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
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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 35 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
排除标准
- •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currently enrolled in or discontinued from a clinical trial within the last 30 days, or have previously completed or withdrawn from this study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
研究组 & 干预措施
75 mg LY3451838 Part A
75 mg LY3451838 single dose administered IV.
干预措施: LY3451838 (Drug)
250 mg LY3451838 Part A
250 mg LY3451838 single dose administered IV.
干预措施: LY3451838 (Drug)
500 mg LY3451838 Part A
500 mg LY3451838 single dose administered IV.
干预措施: LY3451838 (Drug)
1000 mg LY3451838 Part A
1000 mg LY3451838 single dose administered IV.
干预措施: LY3451838 (Drug)
1500 mg LY3451838 Part A
1500 mg LY3451838 single dose administered IV.
干预措施: LY3451838 (Drug)
25 milligram (mg) LY3451838 Part A
25 mg LY3451838 single dose administered intravenously (IV)
干预措施: LY3451838 (Drug)
250 mg LY3451838 Part B
250 mg LY3451838 single dose administered subcutaneously (SC).
干预措施: LY3451838 (Drug)
Placebo
Placebo matching single dose administered IV in Part A or administered SC in Part B.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Any Treatment Emergent Adverse Event
时间窗: Baseline through 20 Weeks
A summary of other non-serious Adverse Events (AE's), and all Serious Adverse Events (SAE's), regardless of causality, is located in the Reported Adverse Events section.
Number of Participants With One or More Serious Adverse Events
时间窗: Baseline through 20 Weeks
A summary of other non-serious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
次要结局
- Pharmacokinetics (PK): Area Under the Serum Concentration-Time Curve From 0 to Infinity (AUC 0 -∞) of LY3451838(Part A: Predose, End of Infusion, 3, 6, 12, 24, 36, 48 h, and Days 5, 7, 9, 15, 22, 29, 43, 57, 71, 85, and 141 post-dose; Part B: Predose, 3, 6, 12, 24, 36, 48 h, and Days 5, 7, 9, 15, 22, 29, 43, 57, 71, 85, and 141 post-dose)
- Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of LY3451838(Part A: Predose, End of Infusion, 3, 6, 12, 24, 36, 48 h, and Days 5, 7, 9, 15, 22, 29, 43, 57, 71, 85, and 141 post-dose; Part B: Predose, 3, 6, 12, 24, 36, 48 h, and Days 5, 7, 9, 15, 22, 29, 43, 57, 71, 85, and 141 post-dose)