A Phase 1 Single Ascending Dose Study of NPC-22 in Healthy Adult Males
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- ECG
研究概览
简要总结
The purpose of this trial is to examine the safety and pharmacokinetics of NPC-22 administered in a single ascending dose in healthy adult males.
详细描述
The healthy adult males will be randomized into six arms, and will receive single dose of NPC-22 (five doses, placebo)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Subjects who have provided their own written informed consent
- •Subjects aged ≥20 and <40 years at the time of informed consent
- •Subjects with body weight of ≥50 kg and body mass index (BMI) (kg/m2) of ≥18.5 and <25.0
- •Subjects who were identified to have no health problem on physical examination, physical assessment, laboratory tests, or other examinations at screening by the principal investigator or a sub-investigator
排除标准
- •Subjects with a complication or a history of drug abuse (use of an illicit drug) or alcohol dependence
- •Subjects with a history of severe disease that may recur during the study period
- •Subjects with any concurrent illnesses
- •Subjects who received another study drug within 180 days prior to the start of study drug administration
- •Subjects who donated blood of ≥400 mL within 12 weeks, blood of ≥200 mL within 4 weeks, or blood components within 2 weeks prior to the start of the study
- •Subjects who used any medicinal product (including over the counter drugs except for topical products) or similar product like a dietary supplement (including health food) within 7 days prior to the start of study drug administration
- •Subjects who took any food or beverage containing grapefruit or St. John's wort within 7 days prior to the start of study drug administration
- •Subjects who took any alcohol or caffeine-containing beverage within 3 days prior to the start of study drug administration
- •Subjects who smoked within 90 days prior to the start of study drug administration, or do not agree to stop smoking during the study period
- •Subjects who had a positive result for HBs antigen, HCV antibody, or HIV antigen/antibody, or a positive reaction to syphilis serology or urine drug test at screening
- •Subjects who are unsuitable as a subject in this study in the judgement of the principal investigator or a sub-investigator based on the 12-lead electrocardiogram at screening [e.g., Fridericia's corrected QT (QTcF) interval of ≥450 ms]
- •Subjects who have a familial history of torsades de pointes or long QT syndrome
- •Subjects who are unsuitable as a subject in this study in the judgement of the principal investigator or a sub-investigator by having a deviation from the institutional reference values
- •Subjects who are unsuitable as a subject in this study in the judgement of the principal investigator or a sub-investigator due to other reasons
研究组 & 干预措施
4
Single administration of middle/high dose NPC-22
干预措施: NPC-22 (Drug)
1
Single administration of low dose NPC-22
干预措施: NPC-22 (Drug)
2
Single administration of low/middle dose NPC-22
干预措施: NPC-22 (Drug)
3
Single administration of middle dose NPC-22
干预措施: NPC-22 (Drug)
5
Single administration of high dose NPC-22
干预措施: NPC-22 (Drug)
6
Single administration of placebo dose NPC-22
干预措施: NPC-22 Placebo (Drug)
结局指标
主要结局
ECG
时间窗: 0-7 days post dose
RR, PR, QRS, QT and QTcF interval and heart rate will be measured for assess the safety of single ascending dose of NPC-22
Number and/or rates of subjects with treatment-related adverse events as assessed by hematology tests
时间窗: 0-7 days post dose
Hematology tests will be performed for assessment the safety of single ascending dose of NPC-22
Number and/or rates of subjects with treatment-related adverse events as assessed by blood chemistry tests
时间窗: 0-7 days post dose
Blood chemistry tests will be performed for assessment the safety of single ascending dose of NPC-22
Number and/or rates of subjects with treatment-related adverse events as assessed by urinalysis
时间窗: 0-7 days post dose
Urinalysis will be performed for assessment the safety of single ascending dose of NPC-22
Adverse events
时间窗: 0-7 days post dose
An adverse event will refer to any unfavorable or unintended sign (including an abnormal laboratory finding and abnormality on the 12-lead ECG or in vital signs) and symptom
Body temperature
时间窗: 0-7 days post dose
Body temperature will be measured for assess the safety of single ascending dose of NPC-22
Blood pressure
时间窗: 0-7 days post dose
Blood pressure will be measured for assess the safety of single ascending dose of NPC-22
Pulse rate
时间窗: 0-7 days post dose
Pulse rate will be measured for assess the safety of single ascending dose of NPC-22
次要结局
- Observed plasma concentration(0-7 days post dose)
- Observed urine concentration(0-4 days post dose)