NCT00927459终止1 期
A Placebo-Controlled, Single-Blind, Single-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PRO-040201 in Male and Female Subjects With Hypercholesterolemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Safety and tolerability of PRO-040201
研究概览
简要总结
This study is a Phase 1, single-center, placebo-controlled, single-blind, first-in-human, single-ascending dose study in male and female subjects with high cholesterol. A maximum of 32 subjects is planned for enrollment in this study.
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
- Single (Participant)
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
- •Fasting, stable LDL-C ≥ 160 mg/dL
- •Fasting, stable triglyceride < 400 mg/dL
- •BMI between 22 and 35 kg/m2, inclusive
- •Females must be of non-child bearing potential
- •Males of reproductive potential must agree to practice effective contraception throughout the study and for 3 months following infusion
排除标准
- •Clinically significant endocrine, hematologic, renal, hepatic, pulmonary, uncontrolled psychiatric, or neurologic disease
- •Cancer within 5 years prior to screening
- •History of congestive heart failure or chronic heart failure
- •Uncontrolled cardiac arrhythmias
- •History of coronary heart disease
- •Clinically significant abnormal baseline ECG
- •History of additional risk factors for torsades de pointes
- •Hepatitis B, C, or HIV positive
- •Current diagnosis or known history of liver disease
- •A marked baseline prolongation of QT/QTc interval
- •Known history of fibromyalgia, myopathy, myositis, rhabdomyolysis, any unexplained muscle pain, or a creatine phosphokinase (CPK) >3 x upper limit of normal (ULN) at screening
- •Alanine aminotransferase, AST, GGT, or total bilirubin >2 x ULN at screening
- •Serum creatinine > 1.5 mg/dL
- •Systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg on 2 occasions during screening
- •Concomitant use of medications that prolongs the QT/QTc interval
- •Treatment with lipid lowering therapy within 30 days prior to screening
- •Use of investigational drug within 3 months prior to screening
研究组 & 干预措施
PRO-040201
Experimental
PRO-040201 with placebo control in each cohort
干预措施: PRO-040201 (Drug)
Placebo
Placebo Comparator
PRO-040201 with placebo control in each cohort
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and tolerability of PRO-040201
时间窗: 29 days
次要结局
- Pharmacokinetics of PRO-040201 in Humans(48 hours)
- Pharmacodynamics of PRO-040201 in Humans(29 days)
研究者
研究点 (1)
Loading locations...
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