ACTRN12615001143516已完成1 期
A Phase I, Randomized, Placebo-Controlled, Double-Blind, Single Dose, Escalating Dose and Multiple-Dose Study of the Safety and Pharmacokinetics of RA101495 in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
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
- All
入选标准
- •*Male or female, equal to, or greater than 18 and equal to or less than 65 years of age.
- •*Able to complete the informed consent procedure, including signing and dating the informed consent form.
- •*Females of childbearing potential must have a negative pregnancy test at Screening and within 24 hours prior to dosing of study drug.
- •*Females of childbearing potential and males must agree to use effective birth control. Effective contraception will begin at Screening for females and Day 1 for males, and will continue through Day 29 (28 days after dosing).
- •*Should have received vaccination against Neisseria meningitidis (at least two weeks
- •prior to dosing). Applies to subjects in single-dose cohorts 4 and 5 only and multiple dose
- •cohorts 6 and 7.
排除标准
- •*Positive throat swab for Neisseria meningitidis at Screening or a prior history of meningitis.
- •*Allergy to ciprofloxacin.
- •*Pregnant or nursing females.
- •*Body mass index < 18.0 kg/m2 or > 34.9 kg/m2.
- •*Surgery requiring general anesthesia within 3 months prior to Screening or during the study.
- •*Loss of > 500 mL of blood (by any process, including donation) within 3 months prior to Screening or blood donation during the study.
- •*Participation in any clinical trial and use of any investigational drug within 3 months prior to Screening.
- •*Use of systemic immune suppressive or immune stimulatory prescription drugs within one month prior to Screening.
- •*Use of any prescription or over-the-counter medication (excludes contraceptive pill) within 7 to 14 days prior to Screening, unless approved by both the investigator and the Sponsor.
- •*Positive test for hepatitis B surface antigen or for antibody to either human immunodeficiency virus-1 or human immunodeficiency virus-2 or hepatitis C virus.
- •*Diagnosis of any systemic infection within 6 months of screening.
- •*History of a malignancy within the past 10 years, evidence of, or required treatment for, cancer (except treated basal or squamous cell carcinoma of the skin or cured cervical carcinoma-in-situ).
- •*Screening laboratory test results that are abnormal in the opinion of the principal investigator (tests with abnormal results may be repeated once).
- •*Calculated creatinine clearance of < 80 mL/min (based on the Cockcroft-Gault equation).
- •*Confirmed, clinically significant abnormalities on electrocardiogram (tests with abnormal findings may be repeated once).
- •*Diagnosis of significant medical disease (chronic or active within the past 6 months), including, but not limited to: cardiac disease (e.g., unstable angina, myocardial infarction, congestive heart failure, ventricular arrhythmia), uncontrolled seizure disorder, liver disease, chronic infection (e.g., tuberculosis), or uncontrolled diabetes; diseases judged by the investigator as not clinically significant or as fully resolved will be reviewed with the Sponsor.
- •*Clinically significant abnormal findings on vital signs or physical examination (findings judged by the investigator as not clinically significant will be reviewed with the Sponsor).
- •*Use of any recreational drugs within 3 months prior to Screening.
- •*Unable or unwilling to comply with the requirements of the study in the judgment of the investigator.
研究者
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