jRCT2071210062已完成不适用
Phase I clinical trial of AKP-009 : A single and multiple dose study at additional doses
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 主要终点
- MRT0-t
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Other
- 盲法
- Double Blind
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 性别
- Male
入选标准
- •The subjects are capable of understanding the requirements of this protocol and of providing voluntary written informed consent for participation in this study.
- •Japanese healthy adult male aged 65 years or older in the multiple-dose 20 mg-H group and 20 years through 40 years in the other groups at the time of informed consent
- •Subjects with a BMI of 18.5 or higher and < 25.0 (rounded down at the second decimal place)at the time of screening
- •Subjects appropriate for the study as determined by principal investigator or sub-investigator (hereinafter, "Investigators") based on screening tests
排除标准
- •Subjects with a pre-existing or a history of liver disorder, renal disorder, cerebro-cardiovascular disease, gastrointestinal disorder, hematologic disorder, endocrine disease, or other disease that would be inappropriate for this study
- •Subjects with tendency of drug allergy
- •Subjects with a pre-existing or history of epilepsy or other convulsive disease
- •Subjects with a pre-existing or history of alcohol dependence
- •Subjects with a positive test result for drugs of abuse at the screening test
- •Subjects whose HBs-antigen, HCV-antibody, HIV antigen/antibody, or serologic test for syphilis is positive at the time of screening
- •Subjects whose body weight is <50 kg at the time of screening
- •Subjects undergoing blood draw exceeding 200 mL within 4 weeks or 400 mL within 12 weeks prior to the start of dose in this study, or subjects undergoing pheresis within 2 weeks prior to the start of dose in this study
- •Subjects inappropriate to take part in this study based on the status of drug use within 1 week prior to the start of dose in this study as determined by the investigators
- •Subjects who have taken part in other clinical study within 16 weeks before the start of treatment in this study (but within 12 weeks if the investigational product is already approved)
- •Subjects who received the first dose of vaccination for prevention of new coronavirus infection (COVID-19) within the 2 weeks prior to the screening test
- •Subjects who is otherwise inappropriate for the study as determined by the investigators
结局指标
主要结局
MRT0-t
Pharmacokinetics: MRT0-t
AKP-009 plasma concentrations
Pharmacokinetics: AKP-009 plasma concentrations
Cmax
Pharmacokinetics: Cmax
AUC0-t
Pharmacokinetics: AUC0-t
AUC0-inf
Pharmacokinetics: AUC0-inf
Tmax
Pharmacokinetics: Tmax
half life
Pharmacokinetics: half life
MRT0-inf
Pharmacokinetics: MRT0-inf
ramdaZ
Pharmacokinetics: ramdaZ
CL/F
Pharmacokinetics: CL/F
Vd/F
Pharmacokinetics: Vd/F
AUC0-tau
Pharmacokinetics: AUC0-tau
Ctrough
Pharmacokinetics: Ctrough
medical examinations
Safety: medical examinations
physical findings
Safety: physical findings
electrocardiography
Safety: electrocardiography
laboratory tests
Safety: laboratory tests
endocrinological tests
Safety: endocrinological tests
adverse events
Safety: adverse events
次要结局
未报告次要终点
研究者
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