A Two-Part, Phase 1, Single and Multiple Ascending Dose Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of CAT-2003 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Frequency and severity of adverse events
研究概览
简要总结
This is a two-part Phase 1 placebo-controlled, double-blind, randomized single and multiple ascending dose study. In Part A, CAT-2003 is administered as a single dose; at two doses (1000 and 2000 mg), subjects will return for a second dose of CAT-2003 or placebo after a high fat meal. In Part B, CAT-2003 is administered for 14 consecutive days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provision of written informed consent prior to any study-specific procedure;
- •Good health as determined by medical history, physical examination, vital signs, ECG, and clinical laboratory measurements;
- •Satisfies one of the following:
- •Females not of childbearing potential: non-pregnant and non-lactating; surgically sterile or postmenopausal for 2 years or at least 1 year with a follicle stimulating hormone assessment (FSH) greater than or equal to 40 IU/L; OR
- •Males: surgically sterile, abstinent, or subject or partner is utilizing an acceptable contraceptive method during and 3 months after the last study dose;
排除标准
- •Clinically significant disease that requires a physician's care and/or would interfere with study evaluations
- •Clinically significant electrocardiogram (ECG) abnormalities or laboratory results as assessed by the investigator, such as QTcF >450;
- •Use of any investigational drug or participation in any investigational study within 30 days prior to screening or 5 half-lives of the study agent, whichever is longer;
研究组 & 干预措施
Cohort B1: Dose level 6: CAT 2003 or placebo
Multiple dose for 14 days
干预措施: CAT 2003 (Drug)
Cohort B1: Dose level 6: CAT 2003 or placebo
Multiple dose for 14 days
干预措施: Placebo (Drug)
Cohort A1, Dose Level 1: CAT 2003 or placebo fasting
Single dose
干预措施: CAT 2003 (Drug)
Cohort A1, Dose Level 1: CAT 2003 or placebo fasting
Single dose
干预措施: Placebo (Drug)
Cohort A2, Dose Level 2: CAT 2003 or placebo fasting
Single dose
干预措施: CAT 2003 (Drug)
Cohort A2, Dose Level 2: CAT 2003 or placebo fasting
Single dose
干预措施: Placebo (Drug)
Cohort A3, Dose Level 3: CAT 2003 or placebo fasting
Single dose
干预措施: CAT 2003 (Drug)
Cohort A3, Dose Level 3: CAT 2003 or placebo fasting
Single dose
干预措施: Placebo (Drug)
Cohort A4, Dose Level 4: CAT 2003 or placebo fasting
Single dose
干预措施: CAT 2003 (Drug)
Cohort A4, Dose Level 4: CAT 2003 or placebo fasting
Single dose
干预措施: Placebo (Drug)
Cohort A5, Dose Level 5: CAT 2003 or placebo fasting
Single dose
干预措施: CAT 2003 (Drug)
Cohort A5, Dose Level 5: CAT 2003 or placebo fasting
Single dose
干预措施: Placebo (Drug)
Cohort A2: Dose Level 2: CAT 2003 or placebo fed
Single dose
干预措施: CAT 2003 (Drug)
Cohort A2: Dose Level 2: CAT 2003 or placebo fed
Single dose
干预措施: Placebo (Drug)
Cohort A3: Dose level 3:CAT 2003 or placebo fed
Single dose
干预措施: CAT 2003 (Drug)
Cohort A3: Dose level 3:CAT 2003 or placebo fed
Single dose
干预措施: Placebo (Drug)
Cohort B2: Dose level 7: CAT 2003 or placebo
Multiple dose for 14 days
干预措施: CAT 2003 (Drug)
Cohort B2: Dose level 7: CAT 2003 or placebo
Multiple dose for 14 days
干预措施: Placebo (Drug)
Cohort B3: Dose level 8: CAT 2003 or placebo
Multiple dose for 14 days
干预措施: CAT 2003 (Drug)
Cohort B3: Dose level 8: CAT 2003 or placebo
Multiple dose for 14 days
干预措施: Placebo (Drug)
Cohort B4: Dose level 9: CAT 2003 or placebo
Multiple dose for 14 days
干预措施: CAT 2003 (Drug)
Cohort B4: Dose level 9: CAT 2003 or placebo
Multiple dose for 14 days
干预措施: Placebo (Drug)
结局指标
主要结局
Frequency and severity of adverse events
时间窗: Screening to End of study (up to 4 weeks following randomization)
次要结局
- AUCinf of CAT-2003(Days 1, 7 and 14)
- Cmax of CAT-1004(Days 1, 7 and14)
- Changes from baseline for hematology, chemistry, coagulation and urinalysis(Baseline through End of study (up to 4 weeks))
- Changes from baseline for Physical exams(Baseline through end of study (up to 4 weeks))
- Changes from baseline for ECGs(Baseline through end of study (up to 4 weeks))
- Changes from baseline in vital signs(Baseline through end of study (up to 4 weeks))
- Assess the pharmacodynamic effects of multiple doses of CAT-2003 on triglycerides and other lipids (LDL-C, VLDL-C, VLDL-triglycerides, non-HDL-C, total cholesterol, HDL-C), apoB, lipoprotein(a), and PCSK9 in healthy subjects with mild dyslipidemia(Baseline to end of study (up to 4 weeks))