A Randomized, Double-blind, Placebo-controlled, Single Intravenous Ascending Dose Study of E3112 in Japanese Healthy Adult Male Subjects
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Peak concentration (Cmax) of E3112
研究概览
简要总结
The study (E3112/CP1) is a single-center, randomized, double-blind, placebo-controlled, single intravenous ascending dose study conducted in Japanese healthy adult males to evaluate the pharmacokinetics (PK), safety, and immunogenicity of E3112 following a single intravenous dose of E3112.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Main Inclusion Criteria:
- •Non-smoking, Japanese, male participants, ≥20 and <45 years old at the time of obtaining informed consent
- •Have a Body Mass Index (BMI) ≥18.5 and <25.0 kilograms per meters squared (kg/m^2) at Screening
- •Able to provide written informed consent of their free will
- •Males who were given a full explanation of all the requirements of the protocol, and are willing and able to comply with them
排除标准
- •Main Exclusion Criteria:
- •Male and his partner who do not agree to use a highly effective method of contraception throughout the entire study period, if he has reproductive capacity
- •Male who had or has any malignant tumor, lymphoma, leukaemia, or lymphoproliferative disorders. Clinically significant illness that required medical treatment within 8 weeks or a clinically significant infection within 4 weeks prior to dosing.
- •Evidence of disease that may influence the outcome of the study within 4 weeks prior to dosing
- •Any history of surgical treatment that may affect pharmacokinetic (PK) profiles of study drug at Screening
- •Any suspected clinically abnormal symptom or organ impairment that require medical treatment at Screening or Baseline
- •Receipt of vaccination within 4 weeks prior to dosing
- •History of drug or alcohol dependency or abuse prior to Screening
- •Intake of caffeinated beverages or food within 72 hours prior to dosing
- •Use of prescription drugs within 4 weeks prior to dosing
- •Intake of over-the-counter (OTC) medications within 2 weeks prior to dosing
- •Male who is currently being enrolled in another clinical study or used any investigational drug or device in another clinical study within 16 weeks prior to dosing
- •Male who underwent a blood transfusion within 12 weeks prior to dosing, who donate 400 milliliters (mL) or more of whole blood within 12 weeks prior to dosing, who donate 200 mL or more of whole blood within 4 weeks prior to dosing, or who made a component donation within 2 weeks prior to dosing
研究组 & 干预措施
Cohort 5: E3112
Intravenous E3112 infusion
干预措施: E3112 (Drug)
Cohort 2: E3112
Intravenous E3112 infusion
干预措施: E3112 (Drug)
Cohort 1: Placebo
Intravenous placebo infusion
干预措施: Placebo (Drug)
Cohort 2: Placebo
Intravenous placebo infusion
干预措施: Placebo (Drug)
Cohort 3: Placebo
Intravenous placebo infusion
干预措施: Placebo (Drug)
Cohort 4: Placebo
Intravenous placebo infusion
干预措施: Placebo (Drug)
Cohort 5: Placebo
Intravenous placebo infusion
干预措施: Placebo (Drug)
Cohort 3: E3112
Intravenous E3112 infusion
干预措施: E3112 (Drug)
Cohort 4: E3112
Intravenous E3112 infusion
干预措施: E3112 (Drug)
Cohort 1: E3112
Intravenous E3112 infusion
干预措施: E3112 (Drug)
结局指标
主要结局
Peak concentration (Cmax) of E3112
时间窗: Days 1 to 4, 8, 14, and 28
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: Days 1 to 4, 8, 14, and 28
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 curve (AUC)
时间窗: Days 1 to 4, 8, 14, and 28
AUC is the area under the curve in a plot of concentration of drug in blood plasma against time. AUC represents the total drug exposure over a defined period of time.
Half-life of elimination (t1/2) of E3112
时间窗: Days 1 to 4, 8, 14, and 28
t1/2 is the time required for the concentration of the drug to reach half of its original value.
Clearance of E3112
时间窗: Days 1 to 4, 8, 14, and 28
Clearance 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: Days 1 to 4, 8, 14, and 28
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 vital sign measurement(Baseline; Days 1 to 28)
- Number of participants with an abnormal, clinically significant physical examination measurement(Baseline; Days 1 to 28)
- Number of participants with an abnormal, clinically significant hematology parameter value(Days 1 to 28)
- Number of participants with any serious adverse event and any non-serious adverse event(Days 1 to 28)
- Number of participants with an abnormal, clinically significant blood chemistry parameter value(Days 1 to 28)
- Number of participants with an abnormal, clinically significant urine value(Days 1 to 28)
- Number of participants with an abnormal, clinically significant electrocardiogram (ECG) measurement(Baseline; Days 1 to 28)