A Double-Blind, Placebo-Controlled, Randomized, Dose-Escalating Study of Single and Multiple Oral Doses of Finafloxacin Hydrochloride in Healthy Subjects and a Study of H. Pylori Treatment in Healthy Carriers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 1
- 主要终点
- To evaluate the safety and tolerability of single and multiple oral doses of Finafloxacin HCl 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 Finafloxacin hydrochloride in healthy volunteers. The level of Finafloxacin hydrochloride will be measured in the subjects blood and urine. One part of the study will assess if Finafloxacin hydrochloride eradicates Helicobacter pylori, a stomach bacteria. Another part of the study will assess the activity of the drug in urine.
详细描述
New antibiotics are needed due to the increasing resistance of bacteria to existing antibiotics. Helicobacter pylori (H. pylori) is a bacteria of the stomach and has been shown to cause peptic ulcers and is implicated in gastric cancer. Up to 40% of the population has H. pylori. Current treatments used to eradicate H. pylori are a combination of a number of drugs including antibiotics and drugs which reduce the acid in the stomach. These treatments are complicated and some H. pylori is resistant to the antibiotics used.
This study is the first use of Finafloxacin hydrochloride in man and will examine its safety and make a preliminary study of its effectiveness as a single agent in eradicating H. pylori. The urine of subjects will also be used to test its effectiveness in killing the bacteria which cause urinary tract infections.
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
- Triple (Participant, 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
- •For part C only, Helicobacter pylori carrier status as assessed by a positive result of the urease breath test at screening.
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
A
Rising Single Dose
干预措施: Finafloxacin hydrochloride (Drug)
B
Rising Multiple Dose
干预措施: Finafloxacin hydrochloride (Drug)
C
Open Label H. pylori cohort
干预措施: Finafloxacin hydrochloride (Drug)
结局指标
主要结局
To evaluate the safety and tolerability of single and multiple oral doses of Finafloxacin HCl by assessing adverse events, physical examinations, clinical chemistry examination, hematology, ECG and urinalysis.
时间窗: 7 days
次要结局
- To determine the pharmacokinetic profile of single and multiple oral doses of Finafloxacin HCl in healthy subjects(7 days)
- To determine the bactericidal activity of urine obtained from healthy subjects after administration of Finafloxacin HCl(7 days)
- To explore the activity of multiple oral doses of Finafloxacin HCl against Helicobacter pylori using the effect on the urease breath test in healthy carriers as a model(7 days)