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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- safety Part I
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Double blind, Randomized, Placebo comparison
- 主要目的
- Other
入排标准
- 年龄范围
- 20age old over 至 45age old under（—）
- 性别
- Male
入选标准
- •Male subjects who are aged between 20 and 45 years old, at the time of Informed Consent
- •Subjects who agree that refraining from sexual activity or combining two or more suitable contraceptive methods in observation period
- •Body Mass Index (BMI) between 18.5 kg/m2 and 30.0 kg/m2 (exclusive) , and with weight over 40 kg at screening
- •Subjects judged healthy by the Investigator by all the examination results
- •Have given written informed consent after receiving sufficient explanation upon participation in the study
排除标准
- •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
- •Subjects who have complications or history of kidney disease
- •Subjects who have complications or history of liver disease
- •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
- •Subjects who used drugs or herbal medicine products within 2 weeks before the investigational drug administration or who may need such drugs
- •Subjects who ingested grapefruit, oranges or apples and juice or foods containing them within 72 hours before the investigational drug administration
- •Subjects who took alcohol exceeding 10 units (1 unit: beer 350 mL, wine 150 mL, distilled liquor 45 mL) per week
- •Subjects who habitually ingest coffee, tea, green tea, cola, other caffeinated beverages exceeding 6 cups (1cup:150mL) per day
- •Smokers or subjects who smoked or used nicotine containing products within 6 months before the screening test
- •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
- •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
- •Have surgical operations for 4 weeks before screening tests
- •Subjects with a history of severe or multiple allergies (including latex allergy), or with a history of hypersensitivity reaction to drugs
- •Have a history of drug or alcohol abuse
- •Subjects with significant electrocardiogram abnormalities, including QTcF> 450 msec in screening tests
- •Positive for immunological test (HBs antigen, HCV antibody, HIV, syphilis)
- •Considered unfit for the study by the investigator
结局指标
主要结局
safety Part I
To evaluate the safety and tolerability of single doses of ART-001 in healthy Japanese volunteers
safety Part II
To evaluate the safety and tolerability of repeated doses of ART-001 in healthy Japanese volunteers
次要结局
未报告次要终点
研究者
研究点 (1)
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