NCT03870490已完成1 期
An Open-Label Trial to Assess the Safety and Pharmacokinetics of VNRX-5133 in the Epithelial Lining Fluid of Healthy Adult 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
- 20
- 试验地点
- 1
- 主要终点
- Pharmacokinetics (PK) in Epithelial Lining Fluid (ELF)
研究概览
简要总结
This is a single-center, open-label study to assess safety and pharmacokinetics of VNRX-5133 and cefepime in the epithelial lining fluid in healthy adult male and female subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Willing to participate in the trial, give written informed consent, and comply with the trial restrictions
- •Gender: male or female with a negative serum pregnancy test (β-human chorionic gonadotropin [β-hCG]) at Screening and Day -1; females may be of childbearing potential or of nonchildbearing potential
- •Age: ≥18 years at Screening
- •Weight: ≥50 kg
- •Body mass index (BMI): ≥18 kg/m2 and <30 kg/m2
- •Normal blood pressure (BP), defined as a systolic value ≥90 mm Hg and ≤140 mm Hg and a diastolic value <90 mm Hg (Screening and Day -1)
- •All values for hematology and clinical chemistry tests of blood and urine are either within normal limits of laboratory reporting range (WNL) or defined as permitted exceptions
- •Ability and willingness to abstain from alcohol, from 48 hours (2 days) prior to admission to the Clinical Research Center (CRC) until discharge from the CRC
- •Males who are not surgically sterilized and females of childbearing potential must agree to use highly effective methods of contraception during this trial and for 90 days after the last dose of study drug
- •All over-the-counter (OTC) medications, health supplements, and herbal remedies (eg, St. John's Wort extract) must have been stopped at least 14 days prior to admission to the CRC
- •Suitable veins for cannulation/multiple venipunctures as assessed by the Investigator at Screening
排除标准
- •Employee of the Contract Research Organization (CRO), CRC, or the Sponsor
- •Female who is pregnant, lactating, or at risk of becoming pregnant during this trial or within 90 days after the last dose of study drug
- •Male with a female partner who is pregnant or lactating during this trial or planning to attempt to become pregnant during this trial or within 90 days after the last dose of study drug
- •Use of any investigational drug or device within 30 days prior to Screening (90 days for an injectable biological agent)
- •Presence of a congenital or acquired immunodeficiency syndrome
- •Any evidence or history of clinically significant medical abnormalities on PE or laboratory assessment
- •Clinically significant ECG abnormality
- •Sitting systolic BP >140 mm Hg or diastolic BP >90 mm Hg on a single measurement following at least 5 minutes of rest at Screening
- •History of drug allergy of a severity that required urgent medical treatment such as treatment with epinephrine in an Emergency Department
- •History of any hypersensitivity reaction following administration of a cephalosporin, penicillin, or other β-lactam antibacterial drug or any component of VNRX-5133 for injection formulation
- •History of hypersensitivity to lidocaine, midazolam, fentanyl, or other topical anesthetics/opioids in similar classes to these agents
- •Use of prescription or nonprescription drugs, vitamins, or dietary supplements within 14 days prior to the first dose of study drug
- •History of donation of >450 mL of blood within 60 days prior to first dose of study drug or planned donation before 30 days has elapsed since final dose of study drug
- •Plasma or platelet donation within 7 days of first dose of study drug or planned donation during this trial
- •Current suspected drug or alcohol abuse as specified in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision criteria
- •Recent history of alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for men (1 standard drink=5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor) within 6 months before Screening
- •Use of tobacco- or nicotine-containing products from Screening through Check Out
研究组 & 干预措施
Healthy Subjects
Experimental
VNRX-5133 + cefepime
干预措施: VNRX-5133 + cefepime (Drug)
结局指标
主要结局
Pharmacokinetics (PK) in Epithelial Lining Fluid (ELF)
时间窗: Day 2
Steady-state plasma PK and disposition of cefepime/VNRX-5133 in the ELF
Safety as measured by the number of subjects with adverse events
时间窗: Days 1-7
Number of Subjects with AEs (Assessed via patient report, physical exam, ECGs, vital signs, laboratory investigations, and use of concomitant medications for the treatment of AEs)
次要结局
未报告次要终点
研究者
研究点 (1)
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