A Randomized, Double-Blind, Placebo-Controlled, Ascending Single to Multi-Dose Study of Safety, Tolerability, and Bioeffect of Subcutaneously Administered REGN727 in Patients With and Without Concomitant Atorvastatin
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- The primary endpoint in the study is to assess the incidence and severity of treatment-emergent adverse events in hyperlipidemic patients treated with REGN727 or placebo receiving stable doses of atorvastatin.
研究概览
简要总结
This study will test the safety, tolerability, and bioeffects (how the body reacts to the drug) of REGN727 compared with placebo (an inactive substance that contains no medicine) in hyperlipidemic patients with or without atorvastatin therapy. The study drug and placebo will be administered by subcutaneous injection at the clinic. There will be a total of 2 or 3 study drug injections over 16 clinic visits, which will include 3 overnight stays(study duration 148 days, not including the screening period). Patients on atorvastatin will take their daily dose in the morning for the duration of the study. Patients will be monitored by the study staff for side effects and the body's response to the study drug. Vital signs(blood pressure, temperature, breathing and heart rate) will be checked, and blood and urine samples will be collected at some or all visits.
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
- 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
- 否
入选标准
- 未提供
排除标准
- •History of MI, ACS, Angina, Stroke, peripheral vascular disease, or cardiac revascularization
- •Pregnant or breast-feeding women
- •Blood donation of any volume within 1 month prior to administration of study drug
- •Congestive heart failure
- •Consumption of greater than 1 quart of grapefruit juice per day
- •Previous exposure to any therapeutic or investigational biological agent within 30 days of screening
- •History of alcohol or drug abuse within one year to the screening visit
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
Group 1 with atorvastatin
Dose 1 versus placebo
干预措施: REGN727(SAR236553) (Drug)
Group 2 with atorvastatin
Dose 1 versus placebo
干预措施: REGN727(SAR236553) (Drug)
Group 3 with atorvastatin
Dose 2 versus placebo
干预措施: REGN727(SAR236553) (Drug)
Group 4 with atorvastatin
Dose 2 versus placebo
干预措施: REGN727(SAR236553) (Drug)
Group 5 with atorvastatin
Dose 3 versus placebo
干预措施: REGN727(SAR236553) (Drug)
Group 6 with atorvastatin
Dose 3 versus placebo
干预措施: REGN727(SAR236553) (Drug)
Group 7 without atorvastatin
Dose 3 versus placebo
干预措施: REGN727(SAR236553) (Drug)
Group 8 with atorvastatin
Dose4 versus placebo
干预措施: REGN727(SAR236553) (Drug)
结局指标
主要结局
The primary endpoint in the study is to assess the incidence and severity of treatment-emergent adverse events in hyperlipidemic patients treated with REGN727 or placebo receiving stable doses of atorvastatin.
时间窗: visit 4 (day 1) to visit 16 (day 148)
次要结局
- To assess the pharmacokinetics of REGN727 in hyperlipidemic patients with or without atorvastatin(Visit 4 (Day 1) to Visit 16 (Day 148))
- To assess the pharmacodynamic effect of monotherapy REGN727 in hyperlipidemic patients(Visit 4 (Day 1) to Visit 16 (Day 148))
- To assess the pharmacodynamic effect of REGN727 added to atorvastatin on lipids(Visit 4 (Day 1) to Visit 16 (Day 148))