A Blinded, Placebo-Controlled, Dose-Escalation, Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of ISIS 681257 Administered Subcutaneously to Healthy Volunteers With Elevated Lipoprotein(a)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To evaluate the safety and tolerability of single and multiple doses of IONIS-APO(a)-LRx (incidence, severity, and dose-relationship of adverse effects and changes in the laboratory parameters)
研究概览
简要总结
The purpose is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of IONIS APO(a)-LRx (ISIS 681257) given to healthy volunteer subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
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
- •Must have given written informed consent and be able to comply with all study requirements
- •Healthy males or females aged 18-65 inclusive and weighing ≥ 50 kg at the time of informed consent
- •Females must be non-pregnant and non-lactating, and either surgically sterile or post- menopausal
- •Males must be surgically sterile, abstinent or using an acceptable contraceptive method
- •BMI < 35.0 kg/m2
- •Subjects must have Lp(a) ≥ 75 nanomoles/liter nmol/L (30 mg/dL) at Screening
排除标准
- •Known history of or positive test for human immunodeficiency virus (HIV), hepatitis C or chronic hepatitis B
- •Treatment with another Study Drug, biological agent, or device within one-month of screening
- •Regular use of alcohol within 6 months of Screening
- •Use of concomitant drugs unless authorized by the Sponsor Medical Monitor
- •Smoking > 10 cigarettes a day
- •Considered unsuitable for inclusion by the Principal Investigator
研究组 & 干预措施
IONIS-APO(a)-LRx
Drug: IONIS-APO(a)-LRx
干预措施: IONIS-APO(a)-LRx (Drug)
Placebo (Normal Saline)
Drug: Sterile Normal Saline (0.9% NaCl)
干预措施: Sterile Normal Saline (0.9% NaCl) (Drug)
结局指标
主要结局
To evaluate the safety and tolerability of single and multiple doses of IONIS-APO(a)-LRx (incidence, severity, and dose-relationship of adverse effects and changes in the laboratory parameters)
时间窗: Up to 113 days
The safety and tolerability of IONIS-APO(a)-LRx will be assessed by determining the incidence, severity, and dose-relationship of adverse effects and changes in the laboratory parameters by dose. Safety results in subjects dosed with IONIS-APO(a)-LRx will be compared with those from subjects dosed with placebo.
To evaluate the pharmacokinetics of single and multiple doses of IONIS-APO(a)-LRx (unconjugated and conjugated ASO)
时间窗: Up to 113 days
The plasma pharmacokinetics of IONIS-APO(a)-LRx (unconjugated and conjugated ASO) will be assessed following single and multiple-dose SC administration. The amount of ISIS-APO(a)-LRx excreted in urine at selected 24-hour intervals will also be determined.
To evaluate the plasma pharmacodynamics of IONIS-APO(a)-LRx (Changes in plasma Lp(a) levels)
时间窗: Up to 113 days
Changes in plasma Lp(a) levels compared to baseline.
次要结局
- Exploratory pharmacodynamic effects of IONIS-APO(a)-LRx(Up to 113 days)