JPRN-jRCT2080224522已完成1 期
Phase I clinical study for safety and pharmacokinetic evaluation of NMB58 in Japanese healthy adult male
ihon Medi-Physics Co., Ltd.0 个研究点目标入组 10 人开始时间: 2019年1月16日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
研究概览
简要总结
Regarding safety, good tolerability was confirmed. As a result of the radiation dosimetry, the absorbed dose after the administration of NMB58 was considered to have a low risk of having a deterministic effect, and the effective dose was also considered to be within an acceptable range compared to existing diagnostic radiopharmaceuticals. NMB58 is considered to have a suitable dynamics as a radiodiagnostic agent for myocardial perfusion imaging.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 40age old（—）
- 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
- •1. Be contracting a disease or having trauma that may affect pharmacokinetics.
- •2. Have a history of prior allergic response to any drugs.
- •3. Be presence of any contraindications (absolute or relative) to exercise stress testing. (For cohort 1subjects)
- •4. Be presence of any contraindications to pharmacologic stress testing with adenosine or administration of aminophylline. (For cohort 2 subjects)
研究者
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