A Phase 1 Study of Single-dose Subcutaneous E6011 in Japanese Healthy Adult Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 主要终点
- Pharmacokinetics of E6011: Maximum Concentration (Cmax)
研究概览
简要总结
This study (Protocol No. E6011-J081-002) is a single-center, randomized, double-blind, placebo-controlled, single ascending dose (SAD) study to evaluate mainly the safety and tolerability of a single subcutaneous administration of E6011. A total of 32 subjects will be randomized into four cohorts (50, 100, 200 and 400 mg groups). Of eight subjects per cohort, six subjects will receive the single subcutaneous E6011 administration and two subjects will receive the single subcutaneous placebo administration.
详细描述
This study consists of Screening Period, Observation Period, In-patient Period, and Follow-up Period. Screening assessments will be performed within 28 to 2 days before starting the study treatment, and Observation Period assessments will be performed on a day before starting the study treatment to confirm the eligibility of study subjects. The eligible subjects will be randomized into either E6011 arm or placebo arm using the drug allocation list prepared by the random code statistician. Each subjects dosing interval will be at least a 30-minutes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
4
Subcutaneous administration of E6011 400 mg
干预措施: E6011 (Drug)
5
Subcutaneous administration of placebo
干预措施: Placebo (Drug)
1
Subcutaneous administration of E6011 50 mg
干预措施: E6011 (Drug)
3
Subcutaneous administration of E6011 200 mg
干预措施: E6011 (Drug)
2
Subcutaneous administration of E6011 100 mg
干预措施: E6011 (Drug)
结局指标
主要结局
Pharmacokinetics of E6011: Maximum Concentration (Cmax)
时间窗: Up to 10 Weeks
Pharmacokinetics of E6011: Time to attain Cmax (tmax)
时间窗: Up to 10 Weeks
Pharmacokinetics of E6011: Area Under the Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration AUC(0-t)
时间窗: Up to 10 Weeks
Pharmacokinetics of E6011: Elimination half-life (t1/2)
时间窗: Up to 10 Weeks
Safety and Tolerability of E6011
时间窗: Up to 10 Weeks
The safety will be assessed based on all adverse events (AEs), clinical laboratory test, vital signs, body weight, physical finding, administration site finding, electrocardiography and chest xray.
Pharmacokinetics of E6011: Area Under the Plasma Concentration-time Profile From Time Zero Extrapolated to Infinite Time AUC(0-inf)
时间窗: Up to 10 Weeks
Pharmacokinetics of E6011: CL/F
时间窗: Up to 10 Weeks
Apparent clearance of drug from plasma following extravascular administration (CL/F) was calculated as dose/AUC(0-?).
Pharmacokinetics of E6011: Apparent Volume of Distribution of Azacitidine (Vz/F)
时间窗: Up to 10 Weeks
次要结局
未报告次要终点