Safety, Tolerability, Pharmacokinetics of Intravenous RPX2014 and RPX7009 in Healthy Adult Subjects
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single- and Multiple Ascending-dose Study of the Safety, Tolerability, and Pharmacokinetics of Intravenous RPX2014 and RPX7009 Alone and in Combination in Healthy Adult Subjects
研究概览
详细说明
The worldwide spread of resistance to antibiotics among Gram-negative bacteria, particularly members of the ESKAPE group of pathogens, has resulted in a crisis in the treatment of hospital acquired infections. In particular, the recent dissemination of a serine carbapenemase (e.g., KPC) in Enterobacteriaceae in US hospitals now poses a considerable threat to the carbapenems and other members of the beta-lactam class of antimicrobial agents.
Rempex is developing a fixed combination antibiotic of a carbapenem (RPX2014) plus a new beta-lactamase inhibitor (RPX7009) which has activity against serine beta-lactamases, including KPC. This Phase 1 study will assess the safety, tolerability and pharmacokinetics of intravenous RPX2014 and RPX7009, administered alone and in combination, in healthy adult subjects.
研究类型
注册 (实际的)
阶段
- 阶段1
联系人和位置
学习地点
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South Australia
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Adelaide、South Australia、澳大利亚、5000
- CMAX
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Healthy adult males and females, 18 to 55 years of age (inclusive) at the time of screening.
- Body mass index (BMI) ≥ 18.5 and ≤ 29.9 (kg/m2) and weight between 55.0 and 100.0 kg (inclusive).
- Medically healthy with clinically insignificant screening results (e.g., laboratory profiles, medical histories, ECGs, physical examination) as deemed by the PI.
- Non-tobacco/nicotine-containing product users for a minimum of Dose Study 6 months prior to Day 1.
- Voluntarily consent to participate in the study.
- Sexually abstinent or agree to use two approved methods of contraception.
Exclusion Criteria:
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
- Positive urine drug/alcohol testing at screening or check-in (Day -1).
- Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HCV).
- History or presence of alcoholism or drug abuse within the 2 years prior to Day 1.
- Use of any over-the-counter (OTC) medication, including herbal products and vitamins, within the 7 days prior to Day 1. Up to 2 grams per day of acetaminophen is allowed for acute events at the discretion of the PI.
- Blood donation or significant blood loss (i.e., > 500 mL) within 56 days prior to Day 1.
- Plasma donation within 7 days prior to Day 1.
- Participation in another investigational clinical trial within 30 days prior to Day 1.
- Subjects who have any abnormalities on laboratory values at screening or check-in (Day -1).
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Single and multiple dose of RPX7009
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Two (2) groups of 15 subjects (12 active and 3 placebo) are planned for evaluation in cohort 1. Cohorts 2-5, 14 subjects (11 active and 3 placebo) are planned for evaluation in each cohort.
14 subjects (12 active and 2 placebo) are planned for evaluation in cohort 6.
其他名称:
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实验性的:Single and multiple dose of RPX2014
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Two (2) groups of 15 subjects (12 active and 3 placebo) are planned for evaluation for cohort 1. Cohorts 2-5, 14 subjects (11 active and 3 placebo) are planned for evaluation in each cohort.
14 subjects (12 active and 2 placebo) are planned for evaluation in cohort 6.
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安慰剂比较:Normal Saline
Single and multiple dose of normal saline
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Two (2) groups of 15 subjects (12 active and 3 placebo) are planned for evaluation for cohort 1. Cohorts 2-5, 14 subjects (11 active and 3 placebo) are planned for evaluation in each cohort.
14 subjects (12 active and 2 placebo) are planned for evaluation in cohort 6.
其他名称:
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实验性的:Combination RPX7009 and RPX2014
Single and Multiple dose of Combination RPX7009 and RPX2014
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Two (2) groups of 15 subjects (12 active and 3 placebo) are planned for evaluation in cohort 1. Cohorts 2-5, 14 subjects (11 active and 3 placebo) are planned for evaluation in each cohort.
14 subjects (12 active and 2 placebo) are planned for evaluation in cohort 6.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Safety from baseline through the end of the study
大体时间:Study Day 1 to Day 14
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Number of patients with adverse events; assessed by patient reporting, collection of vital signs, ECGs and absolute values and changes over time of hematology, chemistry and urinalysis.
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Study Day 1 to Day 14
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Composite of PK parameters RPX7009, RPX2014, combination of RPX7009 and RPX2014 & placebo following single and multiple dose administration.
大体时间:Study Day1 to Day 14
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Plasma AUC0-t, AUC0-inf, Cmax, and Tmax.
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Study Day1 to Day 14
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合作者和调查者
调查人员
- 研究主任:Jeffery Loutit、Sponsor GmbH
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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RPX7009的临床试验
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Rempex Pharmaceuticals (a wholly owned subsidiary...完全的
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Rempex Pharmaceuticals (a wholly owned subsidiary...完全的
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Rempex Pharmaceuticals (a wholly owned subsidiary...完全的
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Rempex Pharmaceuticals (a wholly owned subsidiary...完全的