A Blinded, Placebo-Controlled, Dose-Escalation, Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of ISIS 757456 Administered Subcutaneously to Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Incidence and severity of adverse events that are related to treatment with IONIS AGT-LRx
研究概览
简要总结
The purpose is to assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IONIS AGT-LRx in up to 82 Healthy Volunteers
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 60 Years（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 18-60 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 kg/m
- •Agree to conduct at home blood pressure monitoring (in triplicate using study provided device) every morning and every evening throughout study participation for Single-Dose Cohort subjects and every morning for Multiple-Dose Cohort subjects
排除标准
- •Treatment with another Study Drug, biological agent, or device within one-month of Screening
- •Subject with borderline orthostatic hypotension defined as a fall in systolic blood pressure of ≥ 17 mmHg or diastolic blood pressure of ≥ 7 mmHg when they assume a standing position (within 3 minutes of standing up)
- •Use of nicotine-containing products or illicit drugs
- •Considered unsuitable for inclusion by the Principal Investigator
研究组 & 干预措施
Ionis AGT-LRx
Ascending single and multiple doses of Ionis AGT-LRx administered subcutaneously.
干预措施: Ionis AGT-LRx (Drug)
Placebo
Saline .9%
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence and severity of adverse events that are related to treatment with IONIS AGT-LRx
时间窗: Up to 127 days
The safety and tolerability of single and multiple doses of IONIS AGT-LRx will be assessed by determining the incidence, severity, and dose relationship of adverse events that are related to treatment with IONIS AGT-LRx
Any observed changes in Blood Pressure measurements, ECGs, or laboratory tests from baseline
时间窗: Up to 127 days
The safety and tolerability of single and multiple doses of IONIS AGT-LRx will be assessed by reviewing any observed changes in Blood Pressure measurements, physical exam, and laboratory tests from baseline by dose. Results in subjects dosed with IONIS AGT-LRx will be compared with those from subjects dosed with placebo.
次要结局
- Pharmacodynamics of IONIS AGT-LRx (Changes in plasma AGT Levels)(Up to 127 days)
- Pharmacokinetics after single and multiple doses of IONIS AGT-LRx(Up to 127 days)