A Randomized, Double-Blind, Placebo-Controlled Study in Healthy Japanese Subjects to Assess the Safety, Pharmacokinetics and Immunogenicity of CR6261 Following Single Intravenous Administration
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Number of participants with adverse events
研究概览
简要总结
The purpose of the study is to assess the safety, pharmacokinetics (what the body does to the drug) and immunogenicity (ability of a particular substance to provoke an immune response in the human body) of CR6261 in Japanese healthy participants
详细描述
This study is a randomized (study medication is assigned by chance), double-blind (neither physician nor participant knows the treatment that the participant receives), placebo-controlled (placebo comparator is compared with the study medication to evaluate safety profile of the study medication in clinical study), single-dose study in Japanese healthy adult male participants. The study will include screening phase (28 to 2 days prior to the study medication administration), treatment phase (Study medication will be administered on Day 1), and follow-up phase (up to 76 days). Twelve participants will be randomly assigned to CR6261 50 mg/kg or placebo groups in a 2:1 ratio and receive an assigned treatment on Day 1. Safety will be assessed by evaluating adverse events, clinical laboratory tests, 12-lead Electrocardiogram, vital signs, and physical examination. Total maximum duration of participation of an individual participant will be 104 days.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Have signed an informed consent document
- •Body mass index between 18 and 30 kg/m2, with body weight greater than or equal to 50 kg at screening
- •Must agree to use an adequate contraception method (eg, vasectomy, double-barrier, partner using effective contraception) and to not donate sperm from the study drug administration until Day 76
- •Blood pressure between 90 and 140 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic at screening
- •Non-smoker or participant who smokes no more than 10 cigarettes, or 2 cigars, or 2 pipes of tobacco per day for at least 6 months before the study drug administration
排除标准
- •History of or current clinically significant medical illness determined by the investigators including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, and coagulation disorders
- •Clinically significant abnormal values for hematology, clinical chemistry or urinalysis
- •Clinically significant abnormal physical examination, vital signs or 12-lead electrocardiogram
- •A diagnosis of influenza infection or any constellation of clinical symptoms consistent with influenza infection within 14 days before the study drug administration is scheduled
- •Participants with a fever of over 37.5°C on Day -1 or at predose
研究组 & 干预措施
CR6261
干预措施: CR6261 (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Number of participants with adverse events
时间窗: Up to 76 days
次要结局
- Time to reach the maximum observed serum CR6261 concentration(Day 1 (predose, 0.5, 2.25, 4, and 8 hours), Day 2, Day 3, Day 4, Day 8, Day 15, Day 29, Day 43, Day 57, Day 76 or early withdrawal day)
- Level of antibodies to CR6261 in serum samples(Day 1 (predose), Day 29, Day 57, Day 76 or early withdrawal day)
- Maximum observed serum CR6261 concentration(Day 1 (predose, 0.5, 2.25, 4, and 8 hours), Day 2, Day 3, Day 4, Day 8, Day 15, Day 29, Day 43, Day 57, Day 76 or early withdrawal day)
- Area under the serum CR6261 concentration-time curve(Day 1 (predose, 0.5, 2.25, 4, and 8 hours), Day 2, Day 3, Day 4, Day 8, Day 15, Day 29, Day 43, Day 57, Day 76 or early withdrawal day)