ACTRN12615000601538撤回1 期
A Single-Center, Randomized, Double-Blind, Placebo Controlled, Multiple-Dose, Dose Escalation Study to Evaluate the Safety/Tolerability and Pharmacokinetics of AD 6626 Administered Orally to Normal, Healthy Volunteers
Aldea Pharmaceuticals0 个研究点目标入组 24 人开始时间: 2015年6月9日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 入组人数
- 24
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
入排标准
- 年龄范围
- 21 Years 至 45 Years（—）
- 性别
- All
入选标准
- •This study will be conducted in normal, healthy, adult, male or female aged between 21-45 years and with a BMI greater than or equal to 18 and less than or equal to 30. Eligible subjects will be in good health without signs or symptoms of current illness and with predose clinical and laboratory examinations without clinically significant findings.
排除标准
- •- History of clinically significant endocrine, neurological, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
- •- History of severe allergic or anaphylactic reactions
- •- Fever (body temperature >38 degrees celsius) or symptomatic viral or bacterial infection within 2 weeks prior to Screening
- •- Blood pressure (BP) >140/90 mm Hg or a heart rate (HR) >100 beats per minute at Screening and at Day -1
- •- Clinically significant laboratory abnormalities
- •- Female who is breastfeeding or has a positive pregnancy test at any visit
研究者
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