A Single Center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Pharmacokinetics of One Single Intravenous Dose and 5-day Repeated Intravenous Doses of FBF001 in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 主要终点
- Haematology
研究概览
简要总结
The purpose of this study is to assess the clinical and laboratory safety and to determine the pharmacokinetic profile of FBF001.
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
- 21 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •subject between 21-40 years old
- •with body mass index in the range 18 to 30 Kg/m2
排除标准
- •Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, haematological, neurological, osteo-muscular, articular, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness
- •Any vaccination within three months before the inclusion
- •Any vaccination against H5N1 virus
- •Planned receipt of any vaccine during the study
- •Any infectious disease within the month before the inclusion
- •Any history of animal proteins allergy, animal allergy and/or any drug, food and pollen allergy
- •Who has received blood or plasma derivatives (human or animal) in the three months preceding the initiation of the study
- •Any medication within 14 days before the inclusion or within 5 times the elimination half-life or pharmacodynamic half-life of that drug
研究组 & 干预措施
FBF001
FBF001 must be administered by intravenous route during 1 hour. The dose must be calculated according to the body weight of the subject and diluted in sodium chloride 0.9%.
FBF001 is administered once during 1 day or once per day during 5 days.
干预措施: FBF001 (Biological)
Placebo
The placebo must be administered by intravenous route during 1 hour. It administered once during 1 day or once per day during 5 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Haematology
时间窗: The subjects will be followed during their hospitalization stay (2 days or 6 days) and up to an average of 3 weeks after hospitalization
Normal values of haematology parameters
Blood pressure
时间窗: The subjects will be followed during their hospitalization stay (2 days or 6 days) and up to an average of 3 weeks after hospitalization
mmHg
ECG evaluation
时间窗: The subjects will be followed during their hospitalization stay (2 days or 6 days) and up to an average of 3 weeks after hospitalization
12-lead ECG
Complement activation assay
时间窗: Before dosing, at the end of infusion and 2hours after the beginning
ng/mL
Body weight
时间窗: The subjects will be followed during their hospitalization stay (2 days or 6 days) and up to an average of 3 weeks after hospitalization
kg
Heart rate
时间窗: The subjects will be followed during their hospitalization stay (2 days or 6 days) and up to an average of 3 weeks after hospitalization
bpm
Oral temperature
时间窗: The subjects will be followed during their hospitalization stay (2 days or 6 days) and up to an average of 3 weeks after hospitalization
Celcius degree
Blood chemistry
时间窗: The subjects will be followed during their hospitalization stay (2 days or 6 days) and up to an average of 3 weeks after hospitalization
Normal values of blood chemistry parameters
次要结局
未报告次要终点