ACTRN12616000995471已完成1 期
A Phase I, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Intravenous ETX2514 Administered in Healthy Subjects
INCResearch Australia Pty Ltd0 个研究点目标入组 124 人开始时间: 2016年7月28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
- 124
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 o limit（—）
- 性别
- All
入选标准
- •1. Aged 18 to 55 years (inclusive). In addition, 8 subjects greater than or equal to 65 years of age will be enrolled.
- •2. Be in general good health without clinically significant medical history.
- •3. Provide voluntary written informed consent prior to any study procedures and are willing and able to comply with the prescribed treatment protocol and evaluations.
- •4. Body mass index (BMI) greater than or equal to 18.0 kg/m^2 and less than or equal to 32.0 kg/m^2.
- •5. Clinical laboratory values within the normal limits as defined by the clinical laboratory, unless the Principal Investigator decides that out-of-range values are not clinically significant.
- •6. Negative screen for drugs of abuse, alcohol, hepatitis B surface antigen (HBS Ag), hepatitis C virus antibody (HCV Ab) and Human Immunodeficiency Virus (HIV) at screening; and drugs of abuse, alcohol pre dose on Day -1.
- •7. Female subjects must be of non-childbearing potential, or using a medically acceptable contraceptive regimen and must have a negative pregnancy test at Screening (serum) and on Day -1 (urine) prior to study drug dosing. Male subjects must be surgically sterile, or using a medically acceptable contraceptive regimen.
排除标准
- •1. History of any moderate or severe hypersensitivity or allergic reaction to any beta-lactam antimicrobial (e.g., penicillin, cephalosporin, sulbactam or carbapenem).
- •2. Use of prescription or over the counter medications within 7 days of Investigational Product administration, with the exception of contraceptive medications, paracetamol, oral non-steroidal anti-inflammatory agents, topical over the counter preparations and routine vitamins (if they do not exceed an intake of 20 to 600 times the recommended daily dose), unless agreed as non-clinically relevant by the Principal Investigator and Sponsor.
- •3. Participation in an investigational drug or device study within 30 days before study drug dosing, i.e., there was at least 30 days in between the last dose on a prior study and dose administration on this study.
- •4. Current smoker, or difficulty abstaining from smoking for the duration of study confinement.
- •5. History of major organ dysfunction.
- •6. Infection or any serious underlying medical condition that would impair the subject from receiving study drug.
- •7. History of excessive alcohol intake (more than four standard drinks daily, on average) or use of recreational drugs within the last 3 months.
- •8. Standard donation of blood within 30 days of the study.
- •9. Concomitant disease or condition, including laboratory abnormality, which could interfere with the conduct of the study, or which would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study.
- •10. Anticipated need for surgery or hospitalization during the study
- •11. Unwillingness or inability to comply with the study protocol for any other reason.
研究者
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