JPRN-jRCT2071220050已完成1 期
A randomized, double-blind, placebo-controlled, repeated-dose study to evaluate safety and pharmacokinetics for oral A4250 in healthy Japanese adult subjects
Achiwa Hiroyuki0 个研究点目标入组 9 人开始时间: 2022年9月3日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 9
研究概览
简要总结
The adverse events with a high incidence were gastrointestinal disorders (diarrhoea) as in Study A4250-001 and the adverse events were mild and non-serious and resolved. The results of the PK and PD analyses were similar to these results of Study A4250-001. In conclusion, the PK and PD results for the healthy Japanese adult subjects in this study were similar to those of a non-Japanese clinical study and indicate no safety or tolerability concerns.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 <= 45age old（—）
- 性别
- Male
入选标准
- •Japanese healthy male volunteers aged 18 to 45 years at the time of informed consent
- •- Individuals who weigh 50 kg or more and have a body mass index (BMI) between 18 and 32 kg/m2 (incl) at screening
- •- Those who are able to communicate well with the investigator or subinvestigator and study staff and comply with the requirements of the entire study
- •- Individuals who gave written consent to participate in the study prior to the examination or evaluation of the study
- •- Individuals judged by the investigator (or subinvestigator) to have no health problems at screening based on their medical history, physical findings, vital signs, standard 12-lead ECG, and laboratory test results
- •- Individuals who agree to contraception using a blocked contraceptive device (condom) and female partner's contraception from the time of informed consent to 90 days after the last dose of the investigational product, and who agree that sperm donation is also prohibited during the same period. The principal investigator or subinvestigator will instruct the female partner on the appropriate contraceptive method and the duration of contraception through the subject.
排除标准
- •- Individuals with a history of or suffering from clinically significant acute or chronic disease based on the screening interview and physical findings
- •- Individuals with or without a history of gastrointestinal, hepatic, or renal diseases or other diseases known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
- •- Individuals with a history of drug allergy, food allergy, allergic rash, asthma, intolerance to any drug, hypersensitivity or photosensitivity.
研究者
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