A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending Single and Multiple-Dose Study of the Safety, Tolerability, Pharmacokinetics of Intravenous RPX7009 in Healthy Adult Subjects.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Safety from baseline through 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 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 RPX7009, administered alone, 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 (of Non Child-bearing potential), 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
- •Documented hypersensitivity reaction or anaphylaxis to any medication.
- •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
Ascending Single and Multiple dose of RPX7009
Ascending Single and Multiple dose of RPX7009
干预措施: RPX7009 (Drug)
Normal Saline
Ascending Single and multiple dose of normal saline.
干预措施: Placebo (Drug)
结局指标
主要结局
Safety from baseline through the end of the study.
时间窗: Study Day 1 to Day 13.
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 PK parameters RPX7009 & placebo following single dose administration.(Study Day 1 to Day 12)