ACTRN12609000577213已完成1 期
The pharmacokinetics and clinical tolerability of ascending single doses of BNC210, an anxiolytic compound, in healthy volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 4
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- Male
入选标准
- •1.Good general health without clinically significant renal, hepatic, cardiac or respiratory disease, as determined by the principal investigator.
- •2.Good general mental health as determined by scores on the Symptom Checklist-90-R (SCL-90-R (registered trademark)), a screening instrument which evaluates a broad range of psychological problems and symptoms of psychopathology.
- •3.Agree to and be capable of signing informed consent form.
- •4.Have suitable venous access for blood sampling.
- •5.Body Mass Index within the range of 19-30 kg/m2.
排除标准
- •1.Renal impairment as evidenced by estimated creatinine clearance, measured by the Cockcroft-Gault method of less than 90 mL/min.
- •2.Have a laboratory value at the Screening Visit that is outside the normal range, unless it is judged by the Investigator as not clinically significant after appropriate evaluation.
- •3.A score of more than two standard deviations from the mean on any of the key nine scales in the SCL-90-R (registered trademark)
- •4.Any medical condition that in the opinion of the investigator may adversely impact on the participant’s ability to complete the study.
- •5.Plasma Aspartate transaminase (AST), Alanine transaminase (ALT), and Alkaline phosphatase (ALP) tests in excess of 1.5 times the upper limit of normal.
- •6.History of severe allergic or anaphylactic drug-related reactions.
- •7.Current (within the last six months) clinically significant psychiatric disorder including anxiety or depression.
- •8.Concurrent use of other medication on a regular or daily basis.
- •9.Participation in another clinical trial of an investigational agent within 30 days of study entry.
- •10.Known history of past or present infection with hepatitis C virus (HCV), hepatitis B or human immunodeficiency virus (HIV).
- •11.Clinically significant abnormal electrocardiogram (ECG) (12-lead) at the screening visit or prior to dosing on Day 1, as determined by the Investigator.
- •12.Subjects who have a marked prolongation of the QT corrected (QTc) interval (i.e., repeated demonstration of a QTc interval >450 msec for females or >430 msec for males) at screening or prior to dosing on Day 1 will not be allowed to continue in the study.
- •13.Significant history of illicit drug or alcohol use or abuse (as determined by the Investigator) within 1 year of the Screening Visit.
- •14.Any alcohol use within 24 hours prior to dosing on Day 1.
- •15.Unwillingness or inability to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's returning for follow-up visits on schedule.
- •16.Blood donation (1 unit or more) within 1 month prior to the screening visit.
- •17.Smoke >5 cigarettes per day.
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