Placebo-Controlled, Dose-Escalation Study to Assess Safety, Tolerability, PK and PD of a GalNAc3 Conjugated Antisense Oligonucleotide Targeting ApoC-III, Administered Subcutaneously to Healthy Volunteers With Elevated Triglycerides
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- To evaluate the safety and tolerability of single and multiple doses of IONIS- APOC-III-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 APOC-III-LRx given to healthy volunteer subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •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 Fasting TG ≥ 90 mg/dL or ≥ 200 mg/dL depending on Cohort assignment
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 excessive 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-APOC-III-LRx
Ascending single and multiple doses of IONIS-APOC-III-LRx by subcutaneous (SC) injection
干预措施: Placebo Comparator (Drug)
Placebo (Normal Saline)
Sterile Normal Saline (0.9% NaCl) calculated volume to match active comparator
干预措施: APOC-III-L-Rx (Drug)
结局指标
主要结局
To evaluate the safety and tolerability of single and multiple doses of IONIS- APOC-III-LRx - (incidence, severity, and dose-relationship of adverse effects and changes in the laboratory parameters)
时间窗: Up to 183 days
The safety and tolerability of IONIS- APOC-III-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 APOC-III-LRx will be compared with those from subjects dosed with placebo.
次要结局
- To evaluate the plasma pharmacokinetics of single and multiple doses of IONIS- APOC-III-LRx(Up to 183 days)
- To evaluate the urine pharmacokinetics of single and multiple doses of IONIS¬-APOC-III-LRx(Up to 183 days)