Clinical Study of the Safety and Pharmacokinetics of the Drug Fluorothiazinone (N.F. Gamaleya NRCEM), a Concentrate for Solution Preparation for Infusion With Participation of Adult Healthy Volunteers.
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 70
- 主要终点
- Occurrence of adverse events (AE)
研究概览
简要总结
A two-stage placebo-controlled open-label safety and pharmacokinetics study of the drug Fluorothiazinone, a concentrate for the preparation of an infusion solution, with participation of adult healthy volunteers.
Stage 1 - single administration; dose escalation will be carried out in sequential groups after evaluation of side effects data on day 7.
Stage 2 - course administration of the selected dose.
Total number of healthy replacement volunteers: 5.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
¼ of the full (target) dose (solution, 5 ml)
- st cohort of volunteers: 3 healthy volunteers will receive ¼ of the full (target) dose of the study drug, and 1 healthy volunteer will receive placebo.
- nd cohort of volunteers: in case of AE in 1st cohort, 3 healthy volunteers will receive ¼ of the full (target) dose of the study drug.
干预措施: ¼ of the full (target) dose (solution, 5 ml) (Drug)
¼ of the full (target) dose (solution, 5 ml)
- st cohort of volunteers: 3 healthy volunteers will receive ¼ of the full (target) dose of the study drug, and 1 healthy volunteer will receive placebo.
- nd cohort of volunteers: in case of AE in 1st cohort, 3 healthy volunteers will receive ¼ of the full (target) dose of the study drug.
干预措施: Placebo (Other)
½ of the full (target) dose (solution, 10 ml)
- st cohort of volunteers: 3 healthy volunteers will receive ½ of the full (target) dose of the study drug, and 1 healthy volunteer will receive placebo.
- nd cohort of volunteers: in case of AE in 1st cohort, 3 healthy volunteers will receive ½ of the full (target) dose of the study drug.
干预措施: ½ of the full (target) dose (solution, 10 ml) (Drug)
½ of the full (target) dose (solution, 10 ml)
- st cohort of volunteers: 3 healthy volunteers will receive ½ of the full (target) dose of the study drug, and 1 healthy volunteer will receive placebo.
- nd cohort of volunteers: in case of AE in 1st cohort, 3 healthy volunteers will receive ½ of the full (target) dose of the study drug.
干预措施: Placebo (Other)
full dose (solution, 20 ml)
- st cohort of volunteers: 3 healthy volunteers will receive full (target) dose of the study drug, and 1 healthy volunteer will receive placebo.
- nd cohort of volunteers: in case of AE in 1st cohort, 3 healthy volunteers will receive full (target) dose of the study drug.
干预措施: full dose (solution, 20 ml) (Drug)
full dose (solution, 20 ml)
- st cohort of volunteers: 3 healthy volunteers will receive full (target) dose of the study drug, and 1 healthy volunteer will receive placebo.
- nd cohort of volunteers: in case of AE in 1st cohort, 3 healthy volunteers will receive full (target) dose of the study drug.
干预措施: Placebo (Other)
1 ½ of the full (target) dose (solution, 30 ml)
- st cohort of volunteers: 3 healthy volunteers will receive 1 ½ of the full (target) dose of the study drug, and 1 healthy volunteer will receive placebo.
- nd cohort of volunteers: in case of AE in 1st cohort, 3 healthy volunteers will receive 1 ½ of the full (target) dose of the study drug.
干预措施: 1 ½ of the full (target) dose (solution, 30 ml) (Drug)
1 ½ of the full (target) dose (solution, 30 ml)
- st cohort of volunteers: 3 healthy volunteers will receive 1 ½ of the full (target) dose of the study drug, and 1 healthy volunteer will receive placebo.
- nd cohort of volunteers: in case of AE in 1st cohort, 3 healthy volunteers will receive 1 ½ of the full (target) dose of the study drug.
干预措施: Placebo (Other)
2 full doses (solution, 40 ml)
- st cohort of volunteers: 3 healthy volunteers will receive 2 full (target) doses of the study drug, and 1 healthy volunteer will receive placebo.
- nd cohort of volunteers: in case of AE in 1st cohort, 3 healthy volunteers will receive 2 full (target) doses of the study drug.
干预措施: 2 full doses (solution, 40 ml) (Drug)
2 full doses (solution, 40 ml)
- st cohort of volunteers: 3 healthy volunteers will receive 2 full (target) doses of the study drug, and 1 healthy volunteer will receive placebo.
- nd cohort of volunteers: in case of AE in 1st cohort, 3 healthy volunteers will receive 2 full (target) doses of the study drug.
干预措施: Placebo (Other)
course administration of the selected dose
10 healthy volunteers will receive course administration of the selected dose, and 1 healthy volunteer will receive placebo
干预措施: course administration of the selected dose (Drug)
course administration of the selected dose
10 healthy volunteers will receive course administration of the selected dose, and 1 healthy volunteer will receive placebo
干预措施: Placebo (Other)
结局指标
主要结局
Occurrence of adverse events (AE)
时间窗: within 7 days after administration of the study drug
Occurrence of adverse events (AE) according to CTCAE, v.5.0 (Common Terminology Criteria for Adverse Events).
次要结局
未报告次要终点