ACTRN12614001240639招募中1 期
A randomized, double-blind, placebo-controlled Phase I clinical study to evaluate the safety, tolerability and pharmacokinetics of ZYAN1, a novel PHD-2 Inhibitor, following oral administration in healthy volunteers.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 100
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
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •healthy volunteers
- •- hemoglobin: males - 12.8 - 17.5 g/dl, females - 11.3 - 15.9 g/dl.
- •- B.W. > 55 kg, BMI - 18-30 kg/m2
- •- QTc < 450 msec
- •- females must not be pregnant and males and females must agree to use contraception during the study.
- •- able to give informed consent and comply with protocol.
排除标准
- •- history or presence of severe gastrointestinal or systemic disorders (e.g. respiratory, endocrine, immunological, dermatological, neurological, psychiatric disease etc.)
- •- history or presence of renal insufficiency
- •- active liver disease/ liver transaminase greater than 1.5 X UNL
- •- history or presence of significant alcoholism or drug abuse within past 1 year
- •- history or presence of significant smoking/ consumption of tobacco/nicotine products and positive urine cotinine test at screening and check-in.
- •- difficulty in donating blood
- •- clinically significant laboratory findings during screening
- •- history or presence of clinically significant ECG abnormalities
- •- major illness/ surgery in last 3 months
- •- participated in drug research study within past 3 months
- •- donated 350 mL of blood in last 3 months
- •- used over-the-counter/ prescription/ herbal medications/ supplements within 30 days prior to receiving study drug.
研究者
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