NCT05193851已完成1 期
A Phase I Clinical Study Evaluating the Safety and Pharmacokinetics of Ricolinostat in Chinese Subjects
Beijing 3E-Regenacy Pharmaceuticals Co., Ltd.1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2022年1月12日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- safety of dosed subjects
研究概览
简要总结
This study is an open-label, phase I clinical study to evaluate the safety and pharmacokinetics of ricolinostat in healthy Chinese adult subjects.
详细描述
This study is an open-label, phase I clinical study to evaluate the safety and pharmacokinetics of ricolinostat in healthy Chinese adult subjects.
12 subjects are planned to be enrolled, both male and female, and all will receive the investigational drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Only patients who meet all of the following inclusion criteria can be enrolled in this study:
- •Healthy adult male or female subjects aged 18 to 55 years;
- •Body mass index of 19 - 26 kg/m2 (including the boundary value); the weight of male subjects should not be lower than 50 kg, and the weight of female subjects should not be lower than 45 kg;
- •Subjects have no pregnancy plan and voluntarily take effective contraceptive measures during the study to 3 months after the last dose and have no sperm or egg donation plan.
- •Subjects who fully understand the objective, nature, method and possible adverse reactions of the study, volunteer to be subjects and sign the informed consent form;
- •Able to complete the study according to the protocol requirements.
排除标准
- •Subjects who meet any of the following exclusion criteria are excluded:
- •Allergic to ricolinostat (including excipients) and other similar drugs;
- •Have had a history of drug abuse in the past five years or have used drugs three months before screening, or who have positive result for drug abuse screening at screening;
- •Smokers (people who smoked tobacco products in the past 3 months), or habitual use of nicotine-containing products, or those who are tested positive for nicotine at screening;
- •Drinking more than 14 units of alcohol per week within 6 months before screening (1 unit of alcohol = 360 mL of beer or 45 mL of spirits with 40% alcohol content or 150 mL of wine) or have taken alcoholic products 48 hours before dosing, or tested positive for alcohol breath test;
- •Diseases or factors judged by the investigator to be abnormal and clinically significant, including but not limited to neurological, mental, cardiovascular, blood, liver, kidney, gastrointestinal, respiratory, metabolic, endocrine, immune, skeletal system diseases or other factors;
研究组 & 干预措施
healthy subjects
Experimental
12 healthy Chinese adult subjects, both male and female, are treated with ricolinostat
干预措施: ricolinostat (Drug)
结局指标
主要结局
safety of dosed subjects
时间窗: about one week
monitor AEs
次要结局
未报告次要终点
研究者
研究点 (1)
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