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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 94
- 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 studied in combination with a carbapenem (RPX2014) 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 (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 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
- •Voluntarily consent to participate in the study.
- •Sexually abstinent or agree to use two approved methods of contraception.
排除标准
- •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
- •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.
- •Blood donation or significant blood loss (i.e., > 500 mL) within 56 days prior to Day
- •Plasma donation within 7 days prior to Day
- •Participation in another investigational clinical trial within 30 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
Single and multiple dose of RPX7009
Single and multiple dose of RPX7009
干预措施: RPX7009 (Drug)
Single and multiple dose of RPX2014
Single and multiple dose of RPX2014
干预措施: RPX2014 (Drug)
Normal Saline
Single and multiple dose of normal saline
干预措施: Placebo (Drug)
Combination RPX7009 and RPX2014
Single and Multiple dose of Combination RPX7009 and RPX2014
干预措施: Combination RPX7009 and RPX2014 (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 14
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, RPX2014, combination of RPX7009 and RPX2014 & placebo following single and multiple dose administration.(Study Day1 to Day 14)