NCT02955459已完成1 期
VNRX-5133-101/102: A Randomized, Double Blind, Placebo-Controlled, Sequential Group, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Repeat Doses of VNRX-5133 in Healthy Adult Volunteers
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
- 84
- 主要终点
- Number of subjects with adverse events; assessed by patient reporting, physical exams, collection of vital signs, ECGs and absolute values and changes over time of hematology, chemistry and urinalysis.
研究概览
简要总结
This is a 2-part, first-in-human dose-ranging study to evaluate the safety, tolerability and pharmacokinetics of escalating doses of VNRX-5133 administered via intravenous (IV) infusion in healthy subjects. In part 1, subjects will receive a single dose of VNRX-5133; in part 2 subjects will receive VNRX-5133 for 7 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults
- •Males or non-pregnant, non-lactating females
- •Body Mass Index (BMI) between 18.5 - 32.0, inclusive.
- •Suitable veins for cannulation
排除标准
- •Employee of site or the sponsor
- •Any disease that poses an unacceptable risk to participants
- •Abnormal ECG
- •Abnormal labs
- •Abnormal vital signs
- •Current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, autoimmune, hematologic, neoplastic, or neurological disorder
- •Positive serology for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus (HIV) type 1
- •Current smokers or history of smoking within 30 days
研究组 & 干预措施
VNRX-5133
Experimental
IV infusion
干预措施: VNRX-5133 (Drug)
Placebo
Placebo Comparator
IV infusion
干预措施: Placebo (Drug)
结局指标
主要结局
Number of subjects with adverse events; assessed by patient reporting, physical exams, collection of vital signs, ECGs and absolute values and changes over time of hematology, chemistry and urinalysis.
时间窗: Part 1: 8 days. Part 2: 17 days
次要结局
未报告次要终点
研究者
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