Randomized, Double-Blind, Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-962476 in Healthy Subjects and in Patients With Hypercholesterolemia on Statin Therapy

Bristol-Myers Squibb2 个研究点分布在 1 个国家目标入组 66 人开始时间: 2012年5月最近更新: 2013年9月4日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方
入组人数: 66
试验地点: 2
主要终点: Safety and tolerability of BMS-962476 as measured by the number of subjects with serious adverse events, deaths or discontinuations due to adverse events (AEs), AEs of injection site reactions, or potentially clinically significant changes in vital signs

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

To obtain safety and tolerability information in healthy subjects is administered as a single dose

详细描述

Study Classification: Pharmacokinetics and Pharmacodynamics
Intervention Model: Single Ascending Dose (SAD) study
Allocation: Randomized Non-Stratified

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Single Group
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: 是

入选标准

•Healthy population
•Untreated low density lipoprotein cholesterol (LDL-c) ≥ 130 and ≤ 190 mg/dL and triglycerides ≤ 200 mg/dL
•Body Mass Index (BMI) of 18 to 35 kg/m2 inclusive
•Men and women, ages 18 to 65 years, inclusive
•Statin population
•Patients with hypercholesterolemia on stable statin therapy for 6 weeks prior to enrollment
•At enrollment, LDL-c ≥ 100mg/dL and triglycerides ≤ 200 mg/dL
•Patients with controlled hypertension on a stable dose of no more than two antihypertensive drugs
•BMI of 18 to 37 kg/m2 inclusive
•Men and women, ages 18 to 75 years inclusive

排除标准

•Healthy Population
•Subjects with fasting LDL-c < 130 or > 190 mg/dL, or fasting triglycerides > 200 mg/dL
•Subjects at increased 10-year cardiovascular risk of ≥ 20% based on Framingham risk score
•Subjects with any significant acute or chronic medical illness at the time of screening, including history of cancer, known history of sickle cell disease or trait, and known history of thalassemia
•Statin population
•Patients with fasting LDL-c < 100mg/dL, or fasting triglycerides > 200 mg/dL on statin therapy
•Patients on prescription or over the counter lipid-lowering therapy other than statin therapy
•Patients with established atherosclerotic vascular disease
•Patients with diabetes who are requiring oral or injectable anti-diabetic drug therapy
•Patients with uncontrolled hypertension or controlled hypertension requiring more than two antihypertensive drugs
•Patients with any significant acute or chronic medical illness that is severe, progressive or uncontrolled at the time of screening
•Use of any lipid lowering medication including over the counter products (eg, niacin > 500 mg; omega-3 fatty acids > 1000 mg; red rice yeast; phytosterols or stanol esters) for lipid lowering within 30 days prior to screening visit (42 days for fibrates) with the exception of stable statin therapy in the target disease population
•Prior treatment with any monoclonal antibody or investigational protein biologic within the preceding one year before study drug administration
•Concurrent or use within 3 months of study drug administration of marketed or investigational systemic or inhaled corticosteroids or other immunosuppressant drugs, and within 6 weeks for topical corticosteroids

研究组 & 干预措施

Panel 1: BMS-962476 SC (0.01 mg/Kg) or Placebo

Experimental

BMS-962476 0.01 mg/kg or Placebo matching with BMS-962476 0 mg liquid subcutaneously (SC), Single Dose, 1 day