jRCT2071240097招募中不适用
A Phase I, Randomized, Single-Center, Double-Blind, Placebo-Controlled Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of a Single Dose of AKP-021 in Healthy Male Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 32
- 主要终点
- Safety
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
- 18age old over 至 40age old under（—）
- 性别
- Male
入选标准
- •Capable of understanding the details of the study and can provide written voluntary consent to participate in the study
- •Healthy Japanese male adult aged >=18 years and <=40 years at the time of informed consent
- •BMI >=18.5 and <25.0 at screening tests
- •A participant who has undergone screening and is deemed suitable as a participant in this study by the investigator
排除标准
- •Current or previous diseases considered unsuitable for this study, such as liver disorders, renal disorders, cerebral cardiovascular disorders, gastrointestinal disorders, hematological disorders, and endocrine disorders.
- •Allergic predisposition to a drug or food
- •Current or previous convulsive disorder such as epilepsy
- •Alcohol dependence or history of alcohol dependence
- •Positive drug abuse test result at the screening tests
- •Positive for HBs antigen, HCV antibody, HIV antigen/antibody, or serologic test for syphilis at the screening tests
- •Body weight <50 kg at the screening tests
- •At least 200 mL or 400 mL of blood has been collected within 4 or 12 weeks before receiving the investigational product, respectively, or blood components have been donated within 2 weeks before receiving the investigational product
- •Use of medications within 1 week prior to dosing of the investigational product that the investigator deems to be unsuitable for participation in the study
- •Participated in another clinical study in which an investigational product was received within 16 weeks (or within 12 weeks for an approved investigational product) prior to dosing of the investigational product
- •Any other person who is deemed by the investigator to be unsuitable as a participant in this study or those who are deemed ineligible for this study to be conducted by the investigator due to the possibility of an increased risk associated with participation in the study or the possibility of affecting the interpretation of the results of the study
结局指标
主要结局
Safety
Adverse events, physical findings (medical examination and body weight), vital signs (blood pressure, pulse rate, and body temperature), standard 12-lead electrocardiogram (ECG), and laboratory tests
Pharmacokinetics
Plasma AKP-021 concentration, urinary AKP-021 excretion, plasma AKP-021 metabolite (AKP-021-O-glucuronic acid conjugate) concentration, and pharmacokinetic parameters
Pharmacodynamics
LPS-induced PGE2 concentration in blood sample
次要结局
未报告次要终点
研究者
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