JPRN-jRCT2031210495进行中（未招募）1 期
Physician-Initiated Phase I Study of MA-5 for the Treatment of Mitochondrial Disease-A Phase I Study of MA-5 for the Treatment of Mitochondrial Disease in Healthy Adults
Sambe Takehiko0 个研究点目标入组 56 人开始时间: 2021年12月17日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 56
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 < 45age old（—）
- 性别
- Male
入选标准
- •1) Gender: Male (Japanese)
- •2) Age: 20 years old or older but less than 45 years old (at the time of obtaining consent)
- •3) BMI at the time of screening examination: 18.5 to 25.0 kg/m2 (rounded to the first decimal place)
- •4) Those who are judged to be healthy by the investigator or others as a result of investigations, observations, and tests (clinical examination, 12-lead electrocardiography, etc.) conducted at the time of screening and hospitalization
- •5) Patients who have received sufficient explanation of the contents of the clinical trial from the investigator, understand the purpose of the clinical trial, voluntarily to participate in the clinical trial, and are able to provide written consent of their own free will to participate in the clinical trial, and who are judged to be appropriate for participation in the clinical trial by the investigator.
排除标准
- •1) Those who have used the drug within 7 days prior to the first dose of the investigational drug
- •2) Patients who have a primary disease that affects absorption, metabolism, or excretion of drugs in the gastrointestinal tract, liver, or kidneys, or have a history of previous disease or surgery
- •3) Patients with cardiovascular disease, hypotension, or suspected cardiovascular disease
- •4) Patients with convulsive diseases such as epilepsy or a history of such diseases
- •5) Those who are allergic to drugs or have a history of such allergy
- •6) Persons with a predisposition to allergy who are judged inappropriate by the investigator
- •7) Patients who have a QTc of 450 msec or more or a QTc interval that cannot be measured on a resting 12-lead ECG at screening or prior to Day 1 administration
- •8) Patients with risk factors for torsades de pointes. 8) Patients with uncontrolled hypokalemia or hypomagnesemia, history of heart failure, history of clinically significant bradycardia/symptomatic bradycardia, or QT prolongation syndrome, or family history of sudden unexpected death or congenital QT prolongation syndrome.
- •9) Patients with alcohol or drug dependence or a history of such dependence
- •10) Patients who participated in a clinical trial and received medication within 16 weeks prior to the administration of the investigational drug (except for patch test within 4 weeks prior to the administration of the investigational drug)
- •11) Subjects who have had more than 400 mL of whole blood drawn within 12 weeks prior to the administration of the investigational drug, or more than 200 mL of whole blood drawn within 4 weeks prior to the administration of the investigational drug, or who have donated blood components within 2 weeks prior to the administration of the investigational drug.
- •12) Patients who have tested positive for HBs antigen, HCV antibody, HIV antigen or antibody, or syphilis qualitative test (TP antibody method, RPR method) in the clinical examination conducted at the time of screening.
- •13) Those who are not willing to use appropriate contraception during the clinical trial.
- •14) Those who are judged inappropriate to participate in the clinical trial by the investigator, etc., based on the results of investigations, observations, tests, etc. at the time of screening and hospitalization.
研究者
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