NCT02224079已完成1 期
Safety, Tolerability and Preliminary Pharmacokinetics of Single Rising Doses of 1 mg, 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 37.5 mg, 50 mg, 75 mg, 100 mg, 125 mg and 150 mg BIIB 722 CL (Calculated as 'Free Base') and HPβCD Given as Intravenous Infusion Over 30 Minutes to Young Healthy Male Subjects. A Single-centre, Single-blind, Placebo-controlled, Randomised Study.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 100
- 主要终点
- Number of subjects with adverse events
研究概览
简要总结
Study to assess safety, tolerability and pharmacokinetics (PK) of single intravenous (i.v.) doses of BIIB 722 CL
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
- Single
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy males
- •21 to 50 years of age
- •Broca index >= -20% and <= +20%
- •Written informed consent according to Good Clinical Practice (GCP) and local legislation
排除标准
- •Any finding of the medical examination (including blood pressure, pulse rate and Electrocardiogram (ECG)) deviating from normal and of clinical relevance
- •History or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic or hormonal disorders
- •Diseases of the central nervous system or psychiatric disorders or neurological disorders
- •History of orthostatic hypotension, fainting spells or blackouts
- •Chronic or relevant acute infections
- •History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- •Intake of drugs with a long half-life (> 24 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study
- •Use of any drugs, which might influence the results of the trial within two weeks prior to administration or during the trial
- •Participation in another trial with an investigational drug (<= two months prior to administration or during trial)
- •Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
- •Inability to refrain from smoking on study days
- •Alcohol abuse (> 60 g/day)
- •Drug abuse
- •Blood donation (>= 100 mL within four weeks prior to administration or during the trial)
- •Excessive physical activities (within the last week before the study)
- •Any laboratory value outside the reference range of clinical relevance
研究组 & 干预措施
BIIB 722 CL
Experimental
干预措施: Placebo (Drug)
BIIB 722 CL
Experimental
干预措施: BIIB 722 CL (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Number of subjects with adverse events
时间窗: up to 12 days after drug administration
Number of subjects with clinically significant findings in vital signs
时间窗: up to 12 days after drug administration
blood pressure, pulse rate, respiratory rate, oral body temperature
Number of subjects with clinically significant findings in ECG
时间窗: up to 12 days after drug administration
Number of subjects with clinically significant findings in laboratory tests
时间窗: up to 12 days after drug administration
次要结局
- Plasma concentration time profiles(up to 96 hours after drug administration)
- Time from dosing to the maximum concentration of the analyte in plasma (tmax)(up to 96 hours after drug administration)
- Area under the concentration-time curve of the analyte in plasma from time zero to a specified point in time (AUC0-t)(up to 96 hours after drug administration)
- Terminal half-life of the analyte in plasma (t1/2)(up to 96 hours after drug administration)
- Maximum measured concentration of the analyte in plasma (Cmax)(up to 96 hours after drug administration)
- Amount of drug excreted into urine (Ae)(up to 72 hours after drug administration)
- Mean residence time of the analyte in the body (MRT)(up to 96 hours after drug administration)
- Total clearance of the analyte in plasma (CL)(up to 96 hours after drug administration)
- Apparent volume of distribution at steady state (Vss)(up to 96 hours after drug administration)
研究者
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