A Phase 1, Single-center, Parallel-group, Randomized, Placebo-controlled, Double-blind Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of EB-1020 in Healthy Adult Male Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 主要终点
- Adverse events (AEs)
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
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 18age old over 至 40age old not（—）
- 性别
- Male
入选标准
- •Japanese males age 18 years or older and younger than 40 years at the time of informed consent
- •Body mass index (BMI = body weight(kg)/(height{m})2) of>=19.0kg/m2 and=<25.0kg/m2 at screening
- •Body weight of>=50kg at screening
- •Subjects who are capable of providing their own signed informed consent prior to the start of any trial-related procedure and who are judged by the investigator or subinvestigator to be capable of meeting all of the requirements of the trial
排除标准
- •Subjects who, on the basis of their medical history or the physical examination at either screening or admission, are judged by the investigator or subinvestigator to be placed at risk or to have a clinically significant abnormality that might possibly affect the evaluation endpoints, including drug absorption, distribution, metabolism, or excretion
- •This may include, but is not limited to, a medical history or complication of cardiac, hepatic, renal, neurologic, endocrine, gastrointestinal, respiratory, hematologic, or immunologic disease.
- •Subjects with systolic blood pressure of >140mmHg or <100mmHg or diastolic blood pressure of >90mmHg or <50mmHg after at least 3 minutes rest in the supine, sitting, or standing position (at either screening or admission), or with orthostatic blood pressure decrease (systolic blood pressure in supine position minus systolic blood pressure in standing position) of >=20mmHg(at screening)
- •Subjects whose pulse rate in the supine position after resting for at least 3 minutes is not within the range of 50 to 90bpm(at either screening or admission)
- •Subjects who have a medical history or current symptoms of hepatitis or acquired immunodeficiency syndrome
- •Subjects with a positive result in immunological tests (hepatitis B surface antigen[HBsAg], hepatitis C virus(HCV)antibody, human immunodeficiency virus[HIV] antigen and antibody, syphilis) or polymerase chain reaction (PCR) test (SARS-CoV-2) at screening
- •Subjects with a history of drug allergy
- •Subjects with a positive result in alcohol breath test or urine drug test at screening or admission (positive result for alcohol breath test: concentration of >0.00 mg/L)
结局指标
主要结局
Adverse events (AEs)
Adverse events (AEs)
Clinical laboratory tests
Clinical laboratory tests (hematology, blood chemistry, urinalysis)
Physical examination
Physical examination
Neurological examination
Neurological examination
Vital signs
Vital signs (blood pressure, pulse rate, body temperature, respiratory rate)
Body weight
Body weight
12-Lead electrocardiogram (ECG)
12-Lead electrocardiogram (ECG)
Columbia-Suicide Severity Rating Scale (C-SSRS)
Columbia-Suicide Severity Rating Scale (C-SSRS)
Plasma concentrations of EB-1020 and EB-10601
Plasma concentrations of EB-1020 and EB-10601
Pharmacokinetic parameters of EB-1020 and EB-10601
Pharmacokinetic parameters of EB-1020 and EB-10601
Cumulative parameters of EB-1020 and EB-10601
Cumulative parameters of EB-1020 and EB-10601
AUC ratio for EB-10601 to EB-1020
AUC ratio for EB-10601 to EB-1020
Dose proportionality of Cmax and AUC of EB-1020 and EB-10601
Dose proportionality of Cmax and AUC of EB-1020 and EB-10601
次要结局
未报告次要终点