NCT01264783已完成1 期
Phase I, Double-blind, Randomized, Placebo-controlled, Single-center Study to Assess the Safety and Tolerability of RNS60 Administered Intravenously to Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Tolerability
研究概览
简要总结
The objective of this study is to evaluate the safety and tolerability of RNS60 administered intravenously to healthy subjects. 12 subjects will receive RNS60 or placebo at three escalating rates for 48 hours for each rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Males between 18-55 years
- •Minimum body weight of 60 kg
- •BMI of 18-32 kg/m2
- •Able to execute informed written consent
排除标准
- •A chronic or acute disease that might interfere with the evaluation of the safety of RNS60
- •Current or prior malignancies (excluding history of treated non-melanoma skin carcinoma)
- •Positive viral serology test for HBsAG, Hep C antibody, Hep A IgM, or HIV
- •Use of any prescription medications within 2 weeks of the first day of dosing
- •Significant organ dysfunction, including cardiac, renal, liver, CNS, pulmonary, vascular, GI, endocrine or metabolic
- •Treatment with monoclonal antibody therapy within 5 half-lives prior to the first dose of study medication
- •Treatment with any investigational drugs or therapies within 30 days (or 5 half-lives, whichever is greater) prior to the first dose of study medication
- •Abnormal pre-admission vital signs, physical exam, clinical laboratory, or any safety variable considered clinically significant for this population by the PI
- •Subject is considering or has scheduled any surgical procedure during participation in study
- •History of alcohol and/or dug abuse within 1 year prior to first dose of study medication
- •Subject has donated plasma or blood within 30 days prior to first dose of study medication
- •Subject requires treatment with any medications, either prescription or nonprescription, including dietary supplements or herbal medications, within 14 days prior to the first dose of study medication. Exceptions are nonprescription topical medications (that are not systemically absorbed), acetaminophen, or vitamins at recommended daily doses (not mega dose vitamins)
- •A positive qualitative urine drug or alcohol test
- •Concurrent enrollment in any other clinical trial
- •Subject is judged by PI or Medical Monitor to be inappropriate for the study -
- •Subject has Gilbert's syndrome
- •Subject has estimated creatinine clearance at screening of <90 mL/min.
研究组 & 干预措施
RNS60
Experimental
RNS60
干预措施: RNS60 (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Tolerability
时间窗: 6 days
Safety and tolerability of RNS60 administered by IV infusion to healthy volunteers.
次要结局
- Biomarkers(6 days)
研究者
研究点 (1)
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