ACTRN12619001591145尚未招募1 期
A Phase 1, Open-Label, Single Ascending Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of ES-481 after Oral Administration in Healthy Volunteers
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 80
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
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 55 Years（—）
- 性别
- All
入选标准
- •1.Written informed consent obtained
- •2.The subject is a healthy male or non-childbearing or breast-feeding female or male, 18 to 55 years of age, inclusive
- •3.Body weight 45 to 85 kg, and body mass index (BMI) 18 to 29.9 kg/m2, inclusive.
- •4.If female, is of non-childbearing potential with documentation provided by healthcare professional or post-menopausal [defined as at least 2 years at Screening without menses and with follicle stimulating hormone
- •5.If male, the subject agrees to sexual abstinence, or is surgically sterile or is using a medically acceptable method to prevent pregnancy and agrees to continue using this method from screening until 30 days after the last dose administration
- •6.The subject must have screening and Day -1 clinical laboratory test results within normal limits or, if abnormal, the results are not clinically significant as determined by the Principal Investigator
- •7.Healthy as determined by the Principal Investigator based on Medical History, Physical Examination, Normal Electrocardiograms (ECG) and Normal Electroencephalogram (EEG) recordings done during the screening visit
- •8.Creatinine clearance (CrCL) > 60 mL/min as estimated by the Cockcroft-Gault equation.
- •9.The subject is willing and able to comply with the study requirements
排除标准
- •1.Unwillingness or inability to follow the procedures specified by the protocol.
- •2.History or family history of seizures.
- •3.Major surgery within 3 months or minor surgery within 1 month prior to screening
- •4.The subject has a positive serology test for human immunodeficiency virus, antibody, hepatitis C virus (HCV) antibody or hepatitis B surface antigen (HbsAg) at screening
- •5.The subject has a history of severe allergic or anaphylactic reactions
- •6.The subject has received a vaccine within 60 days prior to study drug administration
- •7.The subject has a history of any clinically significant cardiovascular, gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease or malignancy, excluding non-melanoma skin cancer
- •8.Potential for suicidal ideation as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) during the screening visit
- •9.The subject has any clinically significant abnormality of the physical examination, ECG, EEG and protocol-defined clinical laboratory tests
- •10.Heart rate less than 40 or greater than 90 bpm; systolic blood pressure greater than 140 mm Hg; diastolic blood pressure greater than 90 mm Hg
- •11.A QTc(B) interval of greater than 430 msec (for males) and greater than 450 msec (for females) at Screening or Day -1
- •12.A history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias or torsades de pointes, structural heart disease, or a family history of Long QT Syndrome (LQTS)
- •13.Participated in any interventional clinical study or has been treated with any investigational drugs within 30 days or 5 half-lives prior to the initiation of screening
- •14.The subject is suicidal or has a history of suicide attempt within the past 6 months as determined using the C-SSRS at screening.
- •15.The subject has/had a symptomatic, viral, bacterial or fungal infection within 1 month prior to study drug administration
- •16.Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements, and hormone replacement therapy within 7 days or 5 half-lives,
- •17.Regular use of tobacco or nicotine-containing products within 4 weeks prior to screening or urinary continine level indicative of active smoking at screening and/or at Day -1
- •18.Regular alcohol consumption,
- •19.History of drug abuse within the previous 2 years
- •20.The subject has a positive urine screen for drugs of abuse
- •21.History of CYP3A4 inducer use in the 1 month prior to Day -1 and continuing throughout the study
- •22.The subject has donated or lost greater than or equal to 450 mL of blood or received a transfusion of any blood or blood products within 90 days prior to screening, or has donated plasma within 7 days prior to Day -1
- •23.The subject has any other condition, which in the opinion of the Principal Investigator, precludes the subject’s participation in the study
- •24.Subjects unwilling to abstain from consuming grapefruit, grapefruit juice, or Seville oranges
研究者
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