ACTRN12617001583336已完成1 期
A phase 1, randomized, double-blind, placebo-controlled, sequential-panel, ascending single-dose study to evaluate the safety, tolerability, and pharmacokinetics of intravenous CMX-020 in healthy male and female subjects
Cytometix Inc0 个研究点目标入组 48 人开始时间: 2017年11月27日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
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
入排标准
- 年龄范围
- 18 Years 至 50 Years（—）
- 性别
- All
入选标准
- •To qualify for enrollment in this study, the subject must satisfy the following inclusion criteria:
- •Healthy adult male or adult female between the ages of 18-50 years in good physical health.
- •Of non-childbearing potential or using an acceptable form of contraception
- •Weigh at least 50 kg, and no more than 90and have a body mass index (BMI) between 18 and 32 kg/m2
- •Clinical laboratory results (including clinical chemistry, hematology, and urinalysis) within the reference range for the testing laboratory
- •Negative tox, hepatitis and HIV screens
- •Creatinine clearance of at least 70 mL/min
排除标准
- •Any subject who meets any of the following criteria will not qualify for entry into the study:
- •History of drug abuse, cancer, liver disease, seizure, metabolic disease or head trauma
- •Systolic blood pressure > 140 mm Hg or < 90 mm Hg, or diastolic blood pressure > 90 mm Hg during the Pretreatment Screening or Baseline/Check-in Periods
- •Pulse > 100 beats/minute or < 50 beats/minute during the Pretreatment Screening or Baseline/Check-in Periods
- •Pulse oximetry values <95% on room air; temperature <35.8°C and >37.5°C
- •Clinically significant abnormal ECG at Pretreatment Screening or Baseline/Check-in Periods or history of Long QT Syndrome
- •Clinical laboratory values within the normal limits as defined by the clinical laboratory, unless the investigator decides that out-of-range values are not clinically significant
- •Recent use of alcohol, tobacco, prescription or OTC medications
研究者
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