NCT03747224已完成1 期
A Phase 1 Single and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of ARO-ANG3 in Adult Healthy Volunteers and in Dyslipidemic Patients
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
- 93
- 试验地点
- 6
- 主要终点
- Number of Participants with Adverse Events (AEs) Possibly or Probably Related to Treatment
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetcs and pharmacodynamics of single- and multiple doses of ARO-ANG3 in healthy adult volunteers and in dyslipidemic patients including familial hypercholesterolemia and severe hypertriglyceridemia.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Women of child bearing potential must have a negative pregnancy test, cannot be breastfeeding and must be willing to use contraception
- •Willing to provide written informed consent and to comply with study requirements
- •On a stable diet for at least 4 weeks with no plans to significantly alter diet or weight over course of study
- •Normal electrocardiogram (ECG) at Screening
排除标准
- •Clinically significant health concerns
- •Regular use of alcohol within one month prior to Screening
- •Use of an investigational agent or device within 30 days prior to dosing or current participation in an investigational study
- •Recent use of illicit drugs
- •Use of more than two tobacco/nicotine containing or cannabis products per month within 6 months prior to drug administration (applicable only to Normal Healthy Volunteers)
- •NOTE: additional inclusion/exclusion criteria may apply, per protocol
研究组 & 干预措施
ARO-ANG3
Experimental
干预措施: ARO-ANG3 (Drug)
Placebo
Placebo Comparator
干预措施: sterile normal saline (0.9% NaCl) (Drug)
结局指标
主要结局
Number of Participants with Adverse Events (AEs) Possibly or Probably Related to Treatment
时间窗: Up to 113 (+/- 3 days) post-dose
次要结局
- PK of ARO-ANG3: Time to Maximum Plasma Concentration (Tmax)(Single dose phase: Up to 48 hours post-dose)
- Reduction in Fasting Serum ANGPTL3 from Pre-Dose Baseline(Baseline, Up to Day 113 (+/- 3 days))
- Pharmacokinetics (PK) of ARO-ANG3: Maximum Observed Plasma Concentration (Cmax)(Single dose phase: Up to 48 hours post-dose)
- PK of ARO-ANG3: Area Under the Plasma Concentration Versus Time Curve From Zero to 24 Hours (AUC0-24)(Single dose phase: Up to 48 hours post-dose)
- PK of ARO-ANG3: Terminal Elimination Half-Life (t1/2)(Single dose phase: Up to 48 hours post-dose)
- PK of ARO-ANG3: Area Under the Plasma Concentration Versus Time Curve From Zero to infinity (AUCinf)(Single dose phase: Up to 48 hours post-dose)
研究者
研究点 (6)
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