NCT06482346已完成1 期
Clinical Pharmacology Study of MT-3534 in Healthy Adult Male Volunteers (SAD Study)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Serum concentrations of MT-3534
研究概览
简要总结
This study is planned to investigate the safety, tolerability, and pharmacokinetics when a single intravenous dose of MT-3534 or a placebo is given to healthy adult male volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy adult male volunteer
- •Japanese (Part A) or White (Part B)
- •Subjects with age of 18 to 55 years old at informed consent
- •Subjects with a full understanding of the nature of this study and consented in writing to participate in the study
排除标准
- •Additional screening criteria check may apply for qualification:
- •Subjects with a current or prior disease history of cardiac, hepatic, renal, gastrointestinal, respiratory, neuropsychiatric, hematopoietic, endocrine systems, etc. whom the investigator has judged to be unfit for study participation
- •Subjects with a history of drug or food allergies
- •Subjects with a history of hypersensitivity to any of the ingredients of MT-3534
- •Subjects whose BMI is less than 18.5 kg/m^2 or exceeds 25.0 kg/m^2, or subjects weighing less than 50.0 kg or exceeds 80.0 kg at the time of screening or Day -1 tests (Part A). Subjects whose BMI is less than 18.5 kg/m^2 or exceeds 30.0 kg/m^2, or subjects weighing less than 50.0 kg or exceeds 100.0 kg at the time of screening or Day -1 tests (Part B). (For BMI, values rounded to the first decimal place will be used.)
- •Subjects who have donated blood or from whom blood samples have been collected in a total amount of 400 mL or more in the 12 weeks, 200 mL or more in the 4 weeks, or 800 mL or more in the 52 weeks prior to informed consent
- •Subjects who have donated blood platelets or from whom blood samples have been collected in the 2 weeks prior to informed consent
- •Subjects with a current or prior history of dependence on drugs, alcohol, etc
- •Subjects with a history of cancer
- •Subjects who receive a live attenuated vaccine within 4 weeks before the start of investigational product administration
- •Subjects with a positive result for serological test for syphilis, Hepatitis C virus (HCV) antibody, or HIV antigen/antibody at screening
- •Subjects with a positive result for Hepatitis B virus surface (HBs) antigen, Hepatitis B virus core (HBc) antibody and HBs antibody at screening (Subjects with a negative for HBs antigen plus a positive for HBs antibody plus a negative for HBc antibody and who have obvious history of vaccination are eligible to enroll)
- •Subjects with a history of recurrent infections such as Herpes simplex or Herpes zoster
- •Subjects with a positive result for polymerase chain reaction (PCR) test for COVID-19 at Day -1 test
- •Subjects who do not agree to contraception from the date of informed consent until 12 weeks after the end of the administration of the investigational product
- •Subjects who have participated in other clinical studies and received other investigational products within 12 weeks before informed consent
- •Subjects who have used any drug other than the investigational product in the period within the 7 days before the start of investigational product administration or 5 times the half-life of the drug, whichever is longer
- •Subjects judged by the investigator (or subinvestigator) to be ineligible for the study for any other reason
研究组 & 干预措施
MT-3534
Experimental
Intravenous (IV)
干预措施: MT-3534 (Biological)
Placebo
Placebo Comparator
Intravenous (IV)
干预措施: Placebo (Biological)
结局指标
主要结局
Serum concentrations of MT-3534
时间窗: up to Day 85
Number of subjects with adverse reactions
时间窗: up to Day 85
Number of subjects with adverse events
时间窗: up to Day 85
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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