NCT03427710已完成1 期
A Placebo-controlled, Single Blind, Randomised, Phase I, First In Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered CiVi007 in Subjects With an Elevated LDL C Level
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- LDL Cholesterol
研究概览
简要总结
The primary objective of the study is to assess pharmacokinetics, dynamics, safety and tolerability of CiVi007 following single and multiple subcutaneous doses in subjects, including those on statin therapy
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males or females, of any race, with fasting LDL C >2.6 mmol/L (100 mg/dL) and fasting serum triglycerides <4.52 mmol/L (400 mg/dL)
- •haematology and clinical chemistry without clinically significant abnormal values
- •Normal renal and hepatic function
- •Women must not be pregnant, lactating or of child bearing potential
- •Men must be willing to use appropriate contraception during the study
- •Able to comprehend and willing to sign an ICF and to abide by the study restrictions.
排除标准
- •Any uncontrolled or serious disease, or any medical or surgical condition
- •History or presence of coronary heart disease, peripheral artery disease, or cerebrovascular disease
- •Uncontrolled hypertension
- •Insulin dependent diabetes mellitus
- •Secondary dyslipidemia
- •History of renal or hepatic diseases, acquired immune deficiency syndrome, positive human immunodeficiency virus test and/or history of viral hepatitis B or C
- •History of cancer within 5 years
- •History of high alcohol consumption or positive alcohol breath test or urinary test for drugs of abuse
- •Participation in another clinical study within 3 months prior to screening or participation in another study
- •Use of treatment (e.g. antibody) towards PCSK9
- •History of multiple drug allergies or intolerance to subcutaneous injection.
研究组 & 干预措施
Cohort A1
Experimental
CiVi007 dose 1
干预措施: CiVi007 (Drug)
Cohort A2
Experimental
CiVi007 dose 2
干预措施: CiVi007 (Drug)
Cohort A3
Experimental
CiVi007 dose 3
干预措施: CiVi007 (Drug)
Cohort A4
Experimental
CiVi007 dose 4
干预措施: CiVi007 (Drug)
Cohort A5
Experimental
CiVi007 dose 5
干预措施: CiVi007 (Drug)
Combined placebo group
Placebo Comparator
group response from placebo subsets of dosing cohorts
干预措施: Placebo (Other)
结局指标
主要结局
LDL Cholesterol
时间窗: Maximum post dose within 8 weeks
% LDL-C reduction
次要结局
- Peak Plasma Concentration (Cmax) of CiVi007(8 weeks)
- PCSK9 level(Maximum post dose within 8 weeks)
研究者
研究点 (1)
Loading locations...
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