A Double-Blind, Placebo-Controlled, Randomized, Dose-Escalating Study of Single (Part A) and Multiple (Part B) Intravenous Doses of Friulimicin B in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- To evaluate the safety and tolerability of single and multiple intravenous doses of Friulimicin B by assessing adverse events, physical examinations,clinical chemistry examination, hematology, ECG and urinalysis.
研究概览
简要总结
The purpose of this study is to study the safety of single doses and multiple doses of Friulimicin B in healthy volunteers. The level of Friulimicin B will be measured in the subjects blood and urine. One part of the study will assess if Friulimicin B in the plasma of subjects has activity against bacteria.
详细描述
Continued widespread use of antibiotics has promoted the spread of antibiotic resistance and has created an urgent need for antibacterial agents with no known cross resistance to other antibiotics available for humans. Friulimicin B has been shown to be highly active against a range of bacteria including such important pathogens such as methicillin resistant Staphylococcus aureus (MRSA), drug resistant Streptococcus pneumoniae and Glycopeptide resistant Enterococcus spp. These organisms are the causative agents in serious infections such as skin and soft tissue infections, pneumonia, bacteremia and endocarditis, complicated urinary tract infections, and osteomyelitis.
This study is the first use of Friulimicin B in man and will examine its safety and a preliminary study will assess if Friulimicin B in the plasma of subjects has activity against bacteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- •Male or female healthy subjects
- •18-55 years of age
- •In good health
排除标准
- •Abnormal physical findings of clinical significance at the Screening examination or baseline which would interfere with the objectives of the study.
研究组 & 干预措施
1
Experimental arm with increasing dosage
干预措施: Friulimicin B (Drug)
结局指标
主要结局
To evaluate the safety and tolerability of single and multiple intravenous doses of Friulimicin B by assessing adverse events, physical examinations,clinical chemistry examination, hematology, ECG and urinalysis.
时间窗: 5 days
次要结局
- To determine the pharmacokinetic profile of single and multiple intravenous doses of Friulimicin B in healthy subjects(5 days)
- To determine the bactericidal activity of serum obtained from healthy subjects after administration of Friulimicin B(5 days)