jRCT2071200085已完成不适用
Single-dose study of OMD-001 in healthy adult volunteers
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 主要终点
- -
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
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 20age old over 至 45age old under（—）
- 性别
- Male
入选标准
- •Subjects who signed the written informed consent
- •Age>=20 and =<45 at time of consent
- •Body mass index (BMI) >=18.5 and <25.0
排除标准
- •History of any significant drug allergy.
- •History of drug and/or alcohol abuse
- •History of renal, hepatic, cardiovascular, metabolic, respiratory disease.
- •A positive infection test and/or urine drug screen for substance of abuse at screening.
- •Subjects having taken an following drug and/or food.
- •Prescription and over-the-counter drugs : within the 14 days prior to the administration of investigational drug.
- •The following drugs known to cause photosensitivity : within the 14 days prior to the administration of investigational drug.
- •Tetracycline antibiotics, sulfonamides, new quinolone antibacterial agents, hypericin (Hypericum erectum extract)
- •Supplements containing 5-aminolevulinic acid : within the 14 days prior to the administration of investigational drug.
- •Foods containing St. John's Wort (St. John's Wort) : within the 14 days prior to the administration of investigational drug.
- •Consumption of alcohol: within the 3 days prior to the administration of investigational drug.
- •Subjects who participated in other clinical trials within 16 weeks prior to the administration of investigational drug.
- •Subjects who received 200 mL of blood (donated blood, etc.) within 4 weeks, 400 mL within 12 weeks, or 1200 mL or more within 1 year prior to the administration of investigational drug. and those who donated blood components within 2 weeks.
- •body weight : < 50 kg
- •Subjects who scheduled to visit another hospital during the clinical trial period
- •Subjects who had Clinically significant abnormality at screening phase and judged by the investigator to be unhealthy
- •Subjects who are judged by the investigator to be inappropriate for conducting this clinical study safely.
结局指标
主要结局
-
Pharmacokinetics and Safety
次要结局
未报告次要终点
研究者
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