A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending Single and Multiple-Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous Biapenem (RPX2003) and RPX7009 Given Alone and in Combination in Healthy Adult Subjects.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Safety from baseline to the end of the study
研究概览
简要总结
RPX7009 (beta-lactamase inhibitor) is being studies in combination with a carbapenem biapenem to treat bacterial infections, including those due to multi-drug resistant bacteria.
详细描述
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 (RPX2003 or biapenem) 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 and pharmacodynamics of Intravenous Biapenem and RPX7009, administered alone and in combination in healthy adult subjects.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult males and/or females, 18 to 55 years of age
- •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
- •Non-tobacco/nicotine-containing product users for a minimum of 6 months prior to Day
- •Sexually abstinent or use acceptable methods of birth control
排除标准
- •History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
- •History or presence of alcoholism or drug abuse within the 2 years prior to Day
- •Hypersensitivity or idiosyncratic reaction to beta-lactam antibiotics (e.g. penicillins, cephalosporins, carbapenems, etc.).
- •Use of any over-the-counter (OTC) medication, including herbal products and vitamins, within the 7 days prior to Day
- •Up to 2 grams per day of acetaminophen is allowed for acute events at the discretion of the PI.
- •Plasma donation within 7 days prior to Day
- •Subjects who have any abnormalities on laboratory values at screening or check-in (Day -1).
研究组 & 干预措施
Normal saline
Single and multiple dose of normal saline
干预措施: Normal saline (Drug)
Single dose IV of biapenem or RPX7009
Single dose IV infusion of biapenem or RPX7009
干预措施: RPX7009 (Drug)
Single dose IV of biapenem or RPX7009
Single dose IV infusion of biapenem or RPX7009
干预措施: Biapenem (Drug)
Single dose of biapenem or RPX7009
Single IV dose of biapenem or RPX7009 (for those on active drug, this will be the drug not given in the first IV treatment)
干预措施: RPX7009 (Drug)
Single dose of biapenem or RPX7009
Single IV dose of biapenem or RPX7009 (for those on active drug, this will be the drug not given in the first IV treatment)
干预措施: Biapenem (Drug)
Biapenem and RPX7009 in combination
Single dose followed by a multiple dose of biapenem and RPX7009 in combination
干预措施: RPX7009 (Drug)
Biapenem and RPX7009 in combination
Single dose followed by a multiple dose of biapenem and RPX7009 in combination
干预措施: Biapenem (Drug)
结局指标
主要结局
Safety from baseline to the end of the study
时间窗: Day 1 - Day 17
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.
次要结局
- Composite of Pharmacokinetic (PK) parameters of RPX7009, biapenem & the combination following ascending single and multiple dose administration.(Day 1 - Day 14)
- Composite of Pharmacodynamic (PD) parameters of RPX7009, biapenem & the combination following ascending single and multiple dose administration.(Days 1-14)