NL-OMON33484已完成不适用
A placebo-controlled, double-blind, randomised, multiple dose, dose escalating study in healthy subjects to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of SPC3649 - SPC3649 multiple dose study in healthy volunteers
Santaris Pharma A/S0 个研究点目标入组 30 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 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
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Healthy volunteers
- •Males, postmenopausal (>1 year since last menstruation) or hysterectomised female
- •Age >=18 to 60 years
- •BMI: 18 - 30 kg/m2
- •No clinically significant disease/disorder
- •No clinically significant abnormalities at Screening laboratory tests
- •Male subjects must agree to use birth control (condoms) during the whole study period
- •Following receipt of verbal and written information about the study, the subject must provide signed informed consent before any study related activity is carried out
排除标准
- •Alcohol intake >=21 units weekly for men, and >=14 units for women
- •smoke >10 cigarettes per day
- •Received experimental drug within 60 days of study entry
- •Planned participation in any experimental study during the study period
- •HIV-Ab, HBsAg and/or HCV Ab positive
- •Abnormal blood pressure (systolic >140 mmHg and/or diastolic blood pressure >90 mmHg)
- •Current use of any drug or narcotics
研究者
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