A Phase 1 Clinical Study of a Single Intravenous Dose of E3112 in Japanese Healthy Adult Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Serum Concentrations of E3112
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics after a single intravenous dose of E3112 in Japanese healthy adult male participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 44 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Non-smoking Japanese males aged 20 to 44 years at the time of written, informed consent
- •Body Mass Index (BMI) at screening is 18.5 or more but less than 25.0 kilogram per square metre (kg/m^2)
- •Written, informed consent to participate in the study based on the participant's own free will
- •Willing and able to comply with the requirements in the study after being fully informed of the requirements
排除标准
- •Male participants with reproductive potential who and whose partner do not agree to practice medically appropriate contraception (Note: throughout the study)
- •A history or complication of malignant tumor, lymphoma, leukemia, or lymphoproliferative disorder, a clinically significant disease requiring treatments within 8 weeks before the investigational product treatment, or a history of a clinically significant infection within 4 weeks before the investigational product treatment
- •With a psychiatric, digestive, hepatic, renal, respiratory, endocrine, hematologic, neural, or cardiovascular disease within 4 weeks before the investigational product treatment, a congenital metabolic abnormality, or otherwise a disease that may affect the drug assessments
- •With a surgical history (e.g., resection of the liver, kidney, or digestive tract, etc.) at screening that may affect the pharmacokinetics of the investigational product
- •Suspicion of having a clinically abnormal symptom or an organ impairment that requires treatments based on the history/complications at screening or physical findings, vital signs, electrocardiogram findings, or laboratory values at screening or baseline
- •Testing positive for human immunodeficiency virus (HIV) at screening
- •A positive response to a qualitative test for hepatitis B virus surface antigen (HBs antigen), hepatitis B virus core antigen (HBc) antibody, hepatitis C virus (HCV) antibody, or syphilis
- •Use of a prescription drug within 4 weeks before the investigational product treatment
- •Use of an over-the-counter drug within 2 weeks before the investigational product treatment
- •Receiving a vaccine within 4 weeks before the investigational product treatment
- •Ongoing participation in another clinical study or use of an investigational product or device within 16 weeks before the investigational product treatment while participating in another clinical study
- •Receiving blood transfusion within 12 weeks before the investigational product treatment, providing a whole-blood sample of 400 millilitre (mL) or more between 12 to 4 weeks before the investigational product treatment or a whole-blood sample of 200 mL or more within 4 weeks before the investigational product treatment, or giving blood components by pheresis within 2 weeks before the investigational product treatment
研究组 & 干预措施
Cohort 1 Group A: E3112 + Placebo
E3112 intravenous infusion in treatment stage 1 followed by placebo intravenous infusion in treatment stage 2. A washout period of 7 days will be maintained between the two treatment stages.
干预措施: E3112 (Drug)
Cohort 1 Group A: E3112 + Placebo
E3112 intravenous infusion in treatment stage 1 followed by placebo intravenous infusion in treatment stage 2. A washout period of 7 days will be maintained between the two treatment stages.
干预措施: Placebo (Other)
Cohort 1 Group B: Placebo + E3112
Placebo intravenous infusion in treatment stage 1 followed by E3112 intravenous infusion in treatment stage 2. A washout period of 7 days will be maintained between the two treatment stages.
干预措施: E3112 (Drug)
Cohort 1 Group B: Placebo + E3112
Placebo intravenous infusion in treatment stage 1 followed by E3112 intravenous infusion in treatment stage 2. A washout period of 7 days will be maintained between the two treatment stages.
干预措施: Placebo (Other)
Cohort 2 Group A: E3112 + Placebo
E3112 intravenous infusion in treatment stage 1 followed by placebo intravenous infusion in treatment stage 2. A washout period of 7 days will be maintained between the two treatment stages.
干预措施: E3112 (Drug)
Cohort 2 Group A: E3112 + Placebo
E3112 intravenous infusion in treatment stage 1 followed by placebo intravenous infusion in treatment stage 2. A washout period of 7 days will be maintained between the two treatment stages.
干预措施: Placebo (Other)
Cohort 2 Group B: Placebo + E3112
Placebo intravenous infusion in treatment stage 1 followed by E3112 intravenous infusion in treatment stage 2. A washout period of 7 days will be maintained between the two treatment stages.
干预措施: E3112 (Drug)
Cohort 2 Group B: Placebo + E3112
Placebo intravenous infusion in treatment stage 1 followed by E3112 intravenous infusion in treatment stage 2. A washout period of 7 days will be maintained between the two treatment stages.
干预措施: Placebo (Other)
Cohort 3 Group A: E3112 + Placebo
E3112 intravenous infusion in treatment stage 1 followed by placebo intravenous infusion in treatment stage 2. A washout period of 7 days will be maintained between the two treatment stages.
干预措施: E3112 (Drug)
Cohort 3 Group A: E3112 + Placebo
E3112 intravenous infusion in treatment stage 1 followed by placebo intravenous infusion in treatment stage 2. A washout period of 7 days will be maintained between the two treatment stages.
干预措施: Placebo (Other)
Cohort 3 Group B: Placebo + E3112
Placebo intravenous infusion in treatment stage 1 followed by E3112 intravenous infusion in treatment stage 2. A washout period of 7 days will be maintained between the two treatment stages.
干预措施: E3112 (Drug)
Cohort 3 Group B: Placebo + E3112
Placebo intravenous infusion in treatment stage 1 followed by E3112 intravenous infusion in treatment stage 2. A washout period of 7 days will be maintained between the two treatment stages.
干预措施: Placebo (Other)
Cohort 4 Group A: E3112 + Placebo
E3112 intravenous infusion in treatment stage 1 followed by placebo intravenous infusion in treatment stage 2. A washout period of 7 days will be maintained between the two treatment stages.
干预措施: E3112 (Drug)
Cohort 4 Group A: E3112 + Placebo
E3112 intravenous infusion in treatment stage 1 followed by placebo intravenous infusion in treatment stage 2. A washout period of 7 days will be maintained between the two treatment stages.
干预措施: Placebo (Other)
Cohort 4 Group B: Placebo + E3112
Placebo intravenous infusion in treatment stage 1 followed by E3112 intravenous infusion in treatment stage 2. A washout period of 7 days will be maintained between the two treatment stages.
干预措施: E3112 (Drug)
Cohort 4 Group B: Placebo + E3112
Placebo intravenous infusion in treatment stage 1 followed by E3112 intravenous infusion in treatment stage 2. A washout period of 7 days will be maintained between the two treatment stages.
干预措施: Placebo (Other)
结局指标
主要结局
Serum Concentrations of E3112
时间窗: Day 1: 0-24 hours; Day 8: 0-24 hours
Change from Baseline in Serum Concentration of E3112
时间窗: Day 1: 0-24 hours; Day 8: 0-24 hours
Peak Concentration (Cmax) of E3112
时间窗: Day 1: 0-24 hours; Day 8: 0-24 hours
Cmax is the maximum observed concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administered.
Time to Peak Concentration (Tmax) of E3112
时间窗: Day 1: 0-24 hours; Day 8: 0-24 hours
Tmax is the time from dosing to reach the maximum observed concentration a drug achieves in a specified compartment or test area of the body after the drug has been administered.
Area Under the Concentration-time Curve (AUC 0-t) of E3112
时间窗: Day 1: 0-24 hours; Day 8: 0-24 hours
AUC 0-t is area under the concentration-time curve from time 0 to time of last quantifiable concentration for E3112.
Area Under the Concentration-time Curve (AUC∞) of E3112
时间窗: Day 1: 0-24 hours; Day 8: 0-24 hours
AUC∞ is area under the concentration-time curve from time 0 to infinity of E3112.
Half-life of Elimination (t1/2) of E3112
时间窗: Day 1: 0-24 hours; Day 8: 0-24 hours
t1/2 is the time required for the concentration of the drug to reach half of its original value.
Clearance (CL) of E3112
时间窗: Day 1: 0-24 hours; Day 8: 0-24 hours
CL is defined as the rate of drug elimination divided by the plasma concentration of the drug.
Volume of Distribution (Vd) of E3112
时间窗: Day 1: 0-24 hours; Day 8: 0-24 hours
Vd is the theoretical volume that would be necessary to contain the total amount of an administered drug at the same concentration that it is observed in the blood plasma.
次要结局
- Number of Participants with an Abnormal, Clinically Significant Hematology parameter value(Day 1 to Day 43)
- Number of Participants with Clinically Significant Change in Electrocardiogram (ECG)(Day 1 to Day 43)
- Number of Participants with Clinically Significant Change in Physical Findings(Day 1 to Day 43)
- Number of Participants with Clinically Significant Change in Ophthalmological Findings(Day 1 to Day 43)
- Percentage of Participants with Serum Anti-E3112 Antibodies(Day 1 to Day 43)
- Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)(Day 1 to Day 43)
- Number of Participants with an Abnormal, Clinically Significant Urine Value(Day 1 to Day 43)
- Number of Participants with Clinically Significant Change in Vital Signs(Day 1 to Day 43)
- Number of Participants with an Abnormal, Clinically Significant Clinical Chemistry Parameter Value(Day 1 to Day 43)