NCT04469673已完成1 期
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability and Efficacy, as Well as Immunogenecity, Pharmacokineticks and Pharmacodynamics of Multiple Doses of JS002 on Stable Statin Therapy in Patients With Hyperlipidemia.
Shanghai Junshi Bioscience Co., Ltd.1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2019年5月23日最近更新:
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
- 90
- 试验地点
- 1
- 主要终点
- Percent change from baseline in low-density lipoprotein cholesterol (LDL-C) to week 12
研究概览
简要总结
JS002 is a recombinant humanized anti-PCSK9 monoclonal antibody.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
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
- •Signed informed consent.
- •Age ≥18 and ≤65 years old;
- •Body mass index (BMI) ≥18 and ≤ 30 kg/m2;
- •Subjects who are receiving statin therapy at the time of screening or who are eligible for statin therapy can receive a stable dose of statin therapy for more than 28 days before randomization and are willing to maintain stable statin therapy during the study;
- •Low-density lipoprotein cholesterol (LDL-C) level ≥2.6mmol/L for subjects who are receiving statin and/or other lipid-lowering therapy at the time of screening, or LDL-C≥ 4.1mmol/L for subjects who didn't receive any-lowering therapy at the time of screening, and LDL-C still ≥2.6mmol/L before randomization;
- •Fasting triglycerides ≤4.5 mmol/L;
排除标准
- •Diagnosis of homozygous familial hypercholesterolemia;
- •History of New York heart association (NYHA) defined Ⅱ - Ⅳ heart failure;
- •History of uncontrolled arrhythmiast;
- •History of myocardial infarction, history of PTCA or PCI or CABG, history of unstable angina befor 90 days of randomization;
- •History of stroke or TIA；
- •Uncontrolled hypertension with SBP≥160mmHg and/or DBP≥100mmHg
- •Type 1 diabetes, or type 2 diabetes that is or poorly controlled（HbA1c> 8.0%);
研究组 & 干预措施
JS002
Experimental
Participants received one of 3 dose regimens of JS002 administered as multiple subcutaneous doses.
干预措施: Biological：JS002 (Biological)
Placebo
Placebo Comparator
Participants received matching placebo dose regimens by subcutaneous injection.
干预措施: Placebo (Biological)
结局指标
主要结局
Percent change from baseline in low-density lipoprotein cholesterol (LDL-C) to week 12
时间窗: 12 weeks after the first dose
次要结局
- Absolute value change from baseline in low-density lipoprotein cholesterol (LDL-C)(Twelve weeks after the last dose)
- Percent change from baseline in Total Cholesterol(TC、HDL-C、non-HDL-C、VLDL-C、Apo B、Apo A1、Lp(a) and TG )(Twelve weeks after the last dose)
- Percentage change from baseline TC/HDL-C ratio(Twelve weeks after the last dose)
- Percent change from baseline in Apolipoprotein B (Apo B)(Twelve weeks after the last dose)
- Percent change from baseline in Apolipoprotein A-I (ApoA-I)(Twelve weeks after the last dose)
研究者
研究点 (1)
Loading locations...
相似试验
尚未招募
3 期
Efficacy and Safety of JS002 as Monotherapy in Patients With Primary Hypercholesterolaemia and Mixed DyslipidemiaPrimary Hypercholesterolaemia and Mixed DyslipidemiaNCT05621070Shanghai Junshi Bioscience Co., Ltd.582
已完成
3 期
The Efficacy and Safety of JS002 PFS and AI in Patients With Primary Hypercholesterolemia and Mixed HyperlipidemiaHyperlipemiaNCT05532800Shanghai Junshi Bioscience Co., Ltd.255
已完成
1 期
A Single Dose Escalation Study of PCSK9 Inhibitor (JS002) in Health SubjectsHypercholesterolemiaNCT04197817Shanghai Junshi Bioscience Co., Ltd.84
已完成
3 期
The Safety and Efficacy of Multiple-dose of JS002 in Subject With HyperlipidemiaHyperlipemiaNCT04781114Shanghai Junshi Bioscience Co., Ltd.806
已完成
3 期
A Study to Evaluate the Efficacy and Safety of JS002 in Patients With Heterozygous Familial Hypercholesterolemia (HeFH).Heterozygous Familial HypercholesterolemiaNCT05325203Shanghai Junshi Bioscience Co., Ltd.135