jRCT2080224522已完成1 期
Phase I clinical study for safety and pharmacokinetic evaluation of NMB58 in Japanese healthy adult male
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- -
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
- Non-randomized, Open-label
- 主要目的
- Diagnostic Purpose
入排标准
- 年龄范围
- 20age old over 至 40age old under（—）
- 性别
- Male
入选标准
- •1.Have no history or symptoms of disease that would interfere with the evaluation the subjects, and no clinically significant deviation from normal ranges in screening tests (medical history, physical examination, ECG and clinical laboratory tests (hematology, biochemistry and urinalysis)).
- •2.Expected ability to perform a treadmill exercise stress testing sufficiently to achieve more than 85% of age-predicted maximum heart rate (APMHR). (For cohort 1 subjects)
- •3.Have a body mass index (BMI) of 18 to 28 at the time of screening.
排除标准
- •Be contracting a disease or having trauma that may affect pharmacokinetics.
- •Have a history of prior allergic response to any drugs.
- •Be presence of any contraindications (absolute or relative) to exercise stress testing. (For cohort 1subjects)
- •Be presence of any contraindications to pharmacologic stress testing with adenosine or administration of aminophylline. (For cohort 2 subjects)
结局指标
主要结局
-
safety AEs, vital signs, ECGs, clinical laboratory tests and physical examinations.
次要结局
- radiokinetics of NMB58
- radiation dosimetry of NMB58
研究者
研究点 (1)
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