First in Human Clinical Trial to Compare Safety and Tolerability Between Intravenous Infusions and Bolus Intravenous Inhection of ApTOLL in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Adverse Events
研究概览
简要总结
The main objective of the study is to assess the tolerability and safety of ApTOLL administration when comparing intravenous infusion vs. bolus intravenous injection, in healthy volunteers. Pharmacokinetic profile of ApTOLL will be also analysed as secondary objective of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female (with no possibility to become pregnant (hysterectomized or menopausal women)) subjects who give their written consent to participate in the study.
- •Aged from 18 to
- •No clinically significant organic or psychic conditions.
- •No clinically significant abnormalities in medical records and physical examination.
- •No clinically significant abnormalities in haematology, coagulation, biochemistry, serology and urinalysis .
- •No clinically significant abnormalities in vital signs and electrocardiogram.
排除标准
- •Subjects affected by an organic or psychic condition.
- •Subjects who have received prescribed pharmacological treatment in the last 15 days or any kind of medication in the 48 hours prior to receiving the study medication
- •Subjects with body mass index (weight (kg)/height2 (m2)) outside the 18.5-30.0 range.
- •History of sensitivity to any drug.
- •Positive drug screening (for cannabis, opiates, cocaine and amphetamines).
- •Daily consumers of alcohol and/or acute alcohol poisoning in the last week.
- •Having donated blood in the last month before start of the study.
- •Participation in another study with administration of investigational drugs in the previous 3 months (if the study was conducted with drug substances marketed in Spain, a period of at least 1 month or 5 half lives, what is longer, will be considered).
- •Inability to follow the instructions or collaborate during the study.
研究组 & 干预措施
ApTOLL treatment
Volunteers will receive a dose of ApTOLL of 0.1mg/kg administered intravenously as slow infusion one day and as a single bolus intravenous injection the second day. In a third and last admission day, volunteers will receive a dose of ApTOLL of 0.2mg/kg administered as a single bolus intravenous injection.
干预措施: ApTOLL (Drug)
结局指标
主要结局
Adverse Events
时间窗: day 1 to day 28
To evaluate the safety and tolerability between different ways of ApTOLL administration: intravenous infusion versus bolus intravenous injection, and pharmacokinetic characteristics of ApTOLL in healthy volunteers after single dose administration in fasting conditions.
次要结局
未报告次要终点