JPRN-jRCT2080225277已完成1 期
A Phase 1 study to evaluate the safety, tolerability and pharmacokinetics of single and repeated doses of ART-001 in healthy Japanese male volunteers
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 45age old（—）
- 性别
- Male
入选标准
- •1. Male subjects who are aged between 20 and 45 years old, at the time of Informed Consent
- •2. Subjects who agree that refraining from sexual activity or combining two or more suitable contraceptive methods in observation period
- •3. Body Mass Index (BMI) between 18.5 kg/m2 and 30.0 kg/m2 (exclusive) , and with weight over 40 kg at screening
- •4. Subjects judged healthy by the Investigator by all the examination results
- •5. Have given written informed consent after receiving sufficient explanation upon participation in the study
排除标准
- •1. Have a significant complication which may affect drug evaluation, such as digestive, liver, musculoskeletal, respiratory, brain, cardiovascular, blood, tumor, endocrine, immune, nervous, psychiatric, urogenital diseases, impaired glucose tolerance
- •2. Subjects who have complications or history of kidney disease
- •3. Subjects who have complications or history of liver disease
- •4. Subjects who have a history of surgical operations or medical disorders judged by the investigator that may affect the absorption, distribution, metabolism, excretion of the drug
- •5. Subjects who used drugs or herbal medicine products within 2 weeks before the investigational drug administration or who may need such drugs
- •6. Subjects who ingested grapefruit, oranges or apples and juice or foods containing them within 72 hours before the investigational drug administration
- •7. Subjects who took alcohol exceeding 10 units (1 unit: beer 350 mL, wine 150 mL, distilled liquor 45 mL) per week
- •8. Subjects who habitually ingest coffee, tea, green tea, cola, other caffeinated beverages exceeding 6 cups (1cup:150mL) per day
- •9. Smokers or subjects who smoked or used nicotine containing products within 6 months before the screening test
- •10. Subjects who collected 400 mL or more of blood within 12 weeks or collected 200 mL of blood within 4 weeks or donated blood component within 2 weeks before the study drug administration, or subjects who collected more than 1200 mL of blood per year
- •11. Participation in a clinical trial of an investigational drug within 4 months or of an approved drug within 3 months before the first drug administration
- •12. Have surgical operations for 4 weeks before screening tests
- •13. Subjects with a history of severe or multiple allergies (including latex allergy), or with a history of hypersensitivity reaction to drugs
- •14. Have a history of drug or alcohol abuse
- •15. Subjects with significant electrocardiogram abnormalities, including QTcF> 450 msec in screening tests
- •16. Positive for immunological test (HBs antigen, HCV antibody, HIV, syphilis)
- •17. Considered unfit for the study by the investigator
研究者
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