Multiple Dose Escalation Study of M201-A in Healthy Japanese Subjects
2021年8月29日 更新者:Tomoko Hasunuma、Kitasato University
A Randomized, Double-Blind, Placebo-Controlled, Multiple Continuous Intravenous Injection, Dose Escalation, Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of M201-A in Healthy Japanese Subjects
This Phase I is designed to evaluate the safety, tolerability and pharmacokinetics of multiple ascending doses of M201-A administered by multiple continuous intravenous injection in Healthy Japanese subjects.
研究概览
研究类型
介入性
注册 (实际的)
18
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Tokyo、日本、108-8642
- Clinical Trial Center, Department of Research, KITASATO UNIVERSITY KITASATO INSTITUTE HOSPITAL
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
20年 至 49年 (成人)
接受健康志愿者
是的
有资格学习的性别
男性
描述
Inclusion Criteria:
Subjects must satisfy the following criteria to be enrolled in the study
- (1)Japanese Healthy Male subjects
- (2)Age 20 to less than 50 years of age
- (3)Body Weight of more than 50 kg, Body Mass Index (BMI) of 18.5 to less than 25.0 kg/m2 at the screening examination
- (4)Written informed consent must be obtained on a voluntary basis before any assessment is performed.
Exclusion Criteria:
The presence of any of the following will exclude a subject from enrollment:
- (1)Presence or past medical history of hepatic impairments, renal impairments, cardiovascular disease, gastrointestinal disease and others which are inappropriate for participating in this clinical trial
- (2)Past medical history of cancer, cerebral infarction or cardiac infarction
- (3)Past history of surgical operation of gastrointestine or kidney except appendectomy or hemorrhoid operation.
- (4)Presence or past history of epilepsy.
- (5)Presence or past medical history of allergic reactions or idiosyncrasies to food, medicinal substance and metallic materials
- (6)heart rate(HR) >= 100 bpm at the screening examination
- (7)The corrected QT interval(QTcF) >= 440 ms at the screening examination
- (8)brain natriuretic peptide(BNP) > 40 pg/mL at the screening examination
- (9)K<3.6 mEq/L at the screening examination
- (10)Past history or suspect of aldosteronism.
- (11)Any risk factors of Torsades de Pointes including such as heart failure, hypokalemia, long QT interval syndrome due to family medical history
- (12)Cre>1.10 mg/dL, <0.85 mg/dL at the screening examination
- (13)Subject who donated whole blood of 400 mL within 12 weeks or whole blood of 400 mL of 200 mL / blood component donation within 4weeks prior to the first administration.
- (14)Use of prescription drug, over-the-counter medications (except eye drops for dryness, sanitizer for preventing infection), or herbal medication within 4 weeks prior to study medication.
- (15)Subject who consumed furanocoumarin containing food within 7 days prior to study medication.
- (16)Subject who drunk alcohol or caffeine containing drink within 3 days prior to study medication.
- (17)Subject who was administered of another investigational drug within16 weeks prior to agree to participate in this study.
- (18)Subject who was administered M201-A in the past.
- (19)Subject who smoke within 90 day prior to study medication or who cannot quit smoking during the study period.
- (20)Subject with positive result in hepatitis B(HB)s antigen, hepatitis C virus(HCV) antibody, HIV antigen/antibody, Syphilis serum, urine drug test at the screening test. Subject with positive result in Coronavirus(COVID-19) test at the screening or at the hospitalization.
- (21) Presence or past history of drug/alcohol abuse.
- (22)Subject who do not use medically acceptable contraceptive method until 90 days after the final study drug administration.
- (23)Subject who investigator judges ineligible for other reasons
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:顺序分配
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:M201-A Injection
Active Substance: M201-A Route of administration: continuous intravenous injection
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活性物质:M201-A 给药途径:连续静脉注射
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安慰剂比较:Placebo
Placebo: M201-A Placebo Route of administration: continuous intravenous injection
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Placebo: M201-A Placebo Route of administration: continuous intravenous injection
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Number of participants with adverse events as a measure of safety and tolerability
大体时间:Throughout the study duration up to day 11
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Number of participants with adverse events, serious adverse events, physical examinations, vital sign measurements, 12-lead ECGs, Holter ECG, clinical laboratory safety tests (including hematology, chemistry, and urinalysis), recording of concomitant medications and procedures.
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Throughout the study duration up to day 11
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2020年3月30日
初级完成 (实际的)
2020年11月28日
研究完成 (实际的)
2020年11月30日
研究注册日期
首次提交
2020年7月5日
首先提交符合 QC 标准的
2020年7月8日
首次发布 (实际的)
2020年7月9日
研究记录更新
最后更新发布 (实际的)
2021年8月31日
上次提交的符合 QC 标准的更新
2021年8月29日
最后验证
2021年8月1日
更多信息
与本研究相关的术语
其他研究编号
- M201-A-CT-003
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.