A Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3015014 in Japanese and Non-Japanese Subjects With Elevated LDL-C
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Number of Participants With 1 or More Drug Related Treatment-Emergent Adverse Events (TEAEs) or Any Serious AEs (SAEs)
研究概览
简要总结
This is a phase 1 study in otherwise healthy participants with high LDL cholesterol. Following multiple doses of LY3015014, the safety and tolerability of the drug, how the body handles the drug, and the drug's effect on the body will be evaluated. Participants will participate in the study for approximately 3 months not including screening. Screening is required within 42 days prior to the start of the study.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants must be healthy males or females without childbearing potential as determined by medical history and physical examination, including first-generation Japanese participants
- •Have body mass indexes of 18 to 35 kilograms per meter square (kg/m^2), inclusive, at screening
- •Have screening low-density lipoprotein cholesterol (LDL-C) of between 100 and 180 milligrams per deciliter (mg/dL), inclusive
排除标准
- •Have known allergies to compounds related to LY3015014 or any components of the formulation or known clinically significant hypersensitivity to biologic agents
- •Have a history of atopy, significant allergies to humanized monoclonal antibodies, clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe posttreatment hypersensitivity reactions [including but not limited to erythema multiforme major, linear immunoglobulin (Ig)A dermatosis, toxic epidermal necrolysis, or exfoliative dermatitis)
- •Have significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs, of constituting a risk when taking the study medication, or of interfering with the interpretation of data
- •Have received any vaccine(s) within 1 month of LY3015014 dosing or intend to do so during the study
- •Have received treatment with biologic agents (such as monoclonal antibodies) within 3 months or 5 half-lives (whichever is longer) prior to dosing
研究组 & 干预措施
1.0 milligrams per kilogram (mg/kg) LY3015014 Every 2 Weeks
1.0 mg/kg LY3015014 given subcutaneously (SC) once every 2 weeks for 29 days.
干预措施: LY3015014 (Drug)
1.0 mg/kg LY3015014 Every 4 Weeks
1.0 mg/kg LY3015014 given SC once every 4 weeks for 29 days.
干预措施: LY3015014 (Drug)
3.0 mg/kg LY3015014 Every 2 Weeks
3.0 mg/kg LY3015014 given SC once every 2 weeks for 29 days.
干预措施: LY3015014 (Drug)
3.0 mg/kg LY3015014 Every 4 Weeks
3.0 mg/kg LY3015014 given SC once every 4 weeks for 29 days.
干预措施: LY3015014 (Drug)
Placebo Every 2 Weeks
Saline injection (to match LY3015014) given SC once every 2 weeks for 29 days.
干预措施: Placebo (Other)
Placebo Every 4 Weeks
Saline injection (to match LY3015014) given SC once every 4 weeks for 29 days.
干预措施: Placebo (Other)
结局指标
主要结局
Number of Participants With 1 or More Drug Related Treatment-Emergent Adverse Events (TEAEs) or Any Serious AEs (SAEs)
时间窗: Baseline through study completion (up to Day 127)
TEAEs were defined as SAEs and other non-serious AEs that occurred or worsened after study treatment. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events section of this report.
次要结局
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3015014(First Dose (Day 1) and Last Dose (Day 29): Predose, 4 Hours and 24 Hours Postdose)
- PK: Area Under the Concentration Curve of LY3015014 During 1 Dosing Interval (AUC[0-tau])(First Dose (Day 1) and Last Dose (Day 29): Predose, 4 Hours and 24 Hours Postdose)
- Percent Change From Baseline to Days 43, 57, and 127 in LDL-C(Baseline, Day 43, Day 57, and Day 127)
- PK: Time of Maximum Concentration (Tmax) of LY3015014(First Dose: Predose (Day 1) up to Week 4 postdose and Last Dose: predose (Day 29) up to Week 14 postdose)