ACTRN12616000335493已完成1 期
A Masked, Placebo-Controlled, Dose-Escalation, Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of ISIS 696844 Administered Subcutaneously to Healthy Volunteers
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 25 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Must have given written informed consent and be able to comply with study requirements
- •2. Healthy males or females aged > 25 years at the time of informed consent.
- •3. Females must be non-pregnant and non-lactating, and either surgically sterile or post-menopausal. Males must be surgically sterile, abstinent* or, if engaged in sexual relations with a female of childbearing potential, the subject must be using an acceptable contraceptive method from the time of signing the informed consent until at least 90 days after the subject’s last dose of Study Drug (ISIS 696844 or placebo)
- •4. Body weight > 50 kg at the time of informed consent
排除标准
- •1. Clinical significant abnormalities in medical history, lab tests or physical exam
- •2 Abnormalities in complement.
- •3. Known history of or positive test for human immunodeficiency (HIV), hepatitis C or hepatitis B
- •4. Treatment with another Study Drug, biological agent, or device within one-month of screening
- •5. Use of concomitant drugs unless authorized by the Sponsor Medical Monitor
- •6. Smoking > 10 cigarettes a day
研究者
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