A Phase 2a Randomized, Double-blind, Placebo-controlled, Parallel-designed Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamic Effects of MEDI5884 in Subjects With Stable Coronary Heart Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 133
- 试验地点
- 1
- 主要终点
- Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
研究概览
简要总结
A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamic Effects of MEDI5884 in Adults With Stable Coronary Heart Disease.
详细描述
A Randomized, Double-blind, Placebo-controlled, Parallel-designed Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamic Effects of MEDI5884 in Participants with Stable Coronary Heart Disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of stable coronary heart disease prior to screening
- •Currently receiving high intensity statin(s)
排除标准
- •Unstable cardiovascular conditions
- •Any planned arterial revascularizations
- •Fasting Laboratory values at screening: Triglycerides > 500 mg/dl, Low Density Lipoprotein-Cholesterol > 100 mg/dL
- •Any disease or condition or laboratory value that would place the participant at an unacceptable risk.
研究组 & 干预措施
Placebo
Participants will receive subcutaneous (SC) dose of placebo (volume matched to MEDI5884) on Days 1, 31, and 61.
干预措施: Placebo (Drug)
MEDI5884 50 mg
Participants will receive SC dose of MEDI5884 50 mg on Days 1, 31, and 61.
干预措施: MEDI5884 (Drug)
MEDI5884 100 mg
Participants will receive SC dose of MEDI5884 100 mg on Days 1, 31, and 61.
干预措施: MEDI5884 (Drug)
MEDI5884 200 mg
Participants will receive SC dose of MEDI5884 200 mg on Days 1, 31, and 61.
干预措施: MEDI5884 (Drug)
MEDI5884 350 mg
Participants will receive SC dose of MEDI5884 350 mg on Days 1, 31, and 61.
干预措施: MEDI5884 (Drug)
MEDI5884 500 mg
Participants will receive SC dose of MEDI5884 500 mg on Days 1, 31, and 61.
干预措施: MEDI5884 (Drug)
结局指标
主要结局
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
时间窗: Day 1 (Baseline) through Day 241
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
Number of Participants With Clinically Important Changes in Laboratory Parameters From Baseline
时间窗: Day 1 (Baseline) through Day 241
Number of participants with clinically important changes in laboratory parameters from baseline are reported. Clinically important changes in laboratory parameters is defined as any clinical significant difference in analysis of serum chemistry, hematology, and urine from baseline.
Number of Participants With Clinically Important Changes in Physical Examinations From Baseline
时间窗: Day 1 (Baseline) through Day 241
Number of participants with clinically important changes in physical examinations from baseline are reported. Clinically important changes in physical examinations is defined as any clinical significant difference in general appearance, head, ears, eyes, nose, throat, neck, skin, heart, lung, abdomen, musculoskeletal system, endocrine system, nervous system, height, and weight from baseline.
Number of Participants With Clinically Important Changes in Vital Signs From Baseline
时间窗: Day 1 (Baseline) through Day 241
Number of participants with clinically important changes in vital signs from baseline are reported. Vital signs measurements were obtained after the participant had rested in the supine position for at least 10 minutes at the recording time. Clinically important changes in vital signs from baseline is defined as any clinical significant difference in the vital sign parameters (blood pressure, heart rate, body temperature, and respiratory rate) from baseline.
Number of Participants With Clinically Important Changes in Electrocardiograms (ECGs) From Baseline
时间窗: Day 1 (Baseline) through Day 241
Number of participants with clinically important changes in ECGs from baseline are reported. Clinically important changes in ECGs is defined as any clinical significant difference in heart rate, RR interval, PR interval, QRS, and QT intervals from the primary lead of the digital 12-lead ECG from baseline.
次要结局
- Maximum Observed Serum Concentration (Cmax) of MEDI5884 After the Last Dose(Day 61 (pre-dose), and on Days 64, 68, 71, 91, 111, and 151)
- Number of Participants With Treatment-emergent Anti-drug Antibodies (ADA) to MEDI5884(Day 1 (pre-dose), on Day 8, Day 31 (pre-dose), Day 61 (pre-dose), on Days 151 and 241)
- Change From Baseline in Apolipoprotein B(Day 1 (Baseline), and Days 31, 61, and 91)
- Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C)(Day 1 (Baseline), and Days 31, 61, and 91)
- Terminal Elimination Half-life (t½) of MEDI5884 After the Last Dose(Day 61 (pre-dose), and on Days 64, 68, 71, 91, 111, and 151)
- Area Under the Concentration-time Curve for 30 Days (AUC30d) After the Last Dose of MEDI5884(Day 61 (pre-dose), and on Days 64, 68, 71, and 91)