An Adaptive, Randomized, Double Blind, Placebo Controlled Three Part Study of the Safety, Tolerability, and Pharmacokinetics of MRX-8 Administered Intravenously to Healthy Volunteers in Single Ascending and Multiple Ascending Dose Cohorts
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Time to Peak Plasma Concentration (Tmax)
研究概览
简要总结
This Phase 1 study is designed to assess the safety and tolerability of single and multiple intravenous (IV) doses of MRX-8, to assess the pharmacokinetics of MRX-8 and its primary metabolite following single and multiple IV doses, and to measure the elimination of MRX-8 and its metabolite in urine.
详细描述
This is a first-in-human, randomized, double-blind, placebo-controlled study consisting of 3 parts. Part 1 will evaluate single ascending doses (SAD) of study drug. Part 2 will evaluate multiple ascending doses (MAD) of study drug administered for 7 days. Part 3 will evaluate MAD of study drug administered for 14 days.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Willing and able to provide written informed consent
- •In good general health
排除标准
- •Prior participation in a study utilizing a polymyxin or aminoglycoside antibiotic or other nephrotoxic drug within the 12 months prior to study drug administration on Day 1
- •Use of tobacco or nicotine products, in any form, within 30 days prior to study drug administration on Day 1
- •Venous access considered inadequate for IV infusions, laboratory safety assessments, or PK sample collection
- •Underlying hepatic, renal, metabolic, cardiovascular or immunologic disorders
研究组 & 干预措施
Single intravenous doses of MRX-8
Single escalating doses of MRX-8
干预措施: MRX-8 (Drug)
Single intravenous doses of placebo
Single intravenous doses of placebo to match MRX-8
干预措施: Placebo (Drug)
Multiple intravenous doses of MRX-8 for 7 days
Multiple ascending intravenous doses of MRX-8 every 12 hours for 7 days.
干预措施: MRX-8 (Drug)
Multiple intravenous doses of placebo for 7 days
Multiple intravenous doses of placebo every 12 hours for 7 days to match MRX-8.
干预措施: Placebo (Drug)
Multiple intravenous doses of MRX-8 for 14 days
Multiple ascending intravenous doses of MRX-8 every 12 hours for 14 days.
干预措施: MRX-8 (Drug)
Multiple intravenous doses of placebo for 14 days
Multiple intravenous doses of placebo every 12 hours for 14 days to match MRX-8.
干预措施: Placebo (Drug)
结局指标
主要结局
Time to Peak Plasma Concentration (Tmax)
时间窗: Pre-dose through 48 hours after the end of infusion on the final infusion of study drug
Tmax of MRX-8 and its primary metabolite following single and multiple intravenous doses
Vital signs
时间窗: Pre-dose through 48 hours after the end of infusion on the final infusion of study drug
Heart rate
Peak Plasma Concentration (Cmax)
时间窗: Pre-dose through 48 hours after the end of infusion on the final infusion of study drug
Cmax of MRX-8 and its primary metabolite following single and multiple intravenous doses
Area under the plasma concentration versus time curve (AUC)
时间窗: Pre-dose through 48 hours after the end of infusion on the final infusion of study drug
AUC of MRX-8 and its primary metabolite following single and multiple intravenous doses
Clinical laboratory assessment
时间窗: Pre-dose through 48 hours after the end of infusion on the final infusion of study drug
Complete blood count
Adverse events
时间窗: Pre-dose through 48 hours after the end of infusion on the final infusion of study drug
Symptoms reported by subjects.
次要结局
- Elimination of MRX-8 and its primary metabolite in urine(At the end of infusion through 24 hours after the end of infusion on the final infusion of study drug)