A Phase I, Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability and Pharmacokinetics of Multiple Intravenous Administration of YC-6 in Healthy Chinese Adult Subjects
试验速览
- 阶段
- 1 期
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Number of participants who experience treatment-related adverse events (AEs) and serious adverse events (SAEs)
研究概览
简要总结
The study is designed to determine the safety, tolerability, and pharmacokinetics in healthy subjects with multiple intravenous administration of the neuroprotectant YC-6 compared to placebo.
详细描述
tPA administration within 3-4.5 hours after stroke onset has been the only approved therapy and thus no more than 7% of acute ischemic stroke (AIS) victims worldwide benefited from tPA. A neuroprotectant, YC-6, showed therapeutic effects in preclinical animal models of AIS, indicating its potential as alternative or combined treatment against human AIS.
This randomized, double-blind, placebo-controlled clinical trial is to explore safety and tolerability in healthy Chinese adult volunteers with dose-escalating intravenous infusion of YC-6 for 7 consecutive days. 6 subjects for YC-6 and 2 for placebo will be allocated in each level. Blood and urine samples of each subject will be used in determination of pharmacokinetic properties of the investigational drug.
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
- •18~55 years old healthy subjects
- •BW ≥ 50 kg, BMI 18~28 kg/m²
- •Signed the informed consent from to participate voluntarily and to comply with the trial requirements
排除标准
- •History of clinically significant cardiovascular, hepatic, renal, gastrointestinal, hematologic diseases
- •Clinically significant abnormality evidenced from detailed physical examination, 12-lead ECG, biochemistry, hematology, and routine urine analysis
- •Glomerular filtration rate (GFR) < 80 mL/min
- •Any medication within 2 weeks before the first administration in this study
- •History of clinically significant allergy and hypersensitivity
- •Hepatitis B or C, syphilis, or HIV infection on serological examination
- •History of alcoholic addiction or drug abuse within a year before this study
- •Failing of smoking and drunk cessation (Breath carbon monoxide test > 7 ppm) during this study
- •Participated in any drug trial within 3 months before this study
- •Donated blood or blood product ≥ 400 mL or 2 units within 3 months before this study
- •Dissented to avoid intake of tobacco, alcohol, or caffeine, and strenuous exercise or any behavior that would affect the ADME of YC-6
- •Pregnant or breast-feeding women
- •Other subject conditions unsuitable for enrollment in this study
研究组 & 干预措施
YC-6
6 volunteers in each level will be infused 100, 200, 400, or 600 mg of YC-6 over 7 consecutive days: BID within 30 minutes for the first 6 days and QD on the 7th day.
干预措施: YC-6 (Drug)
Vehicle
2 volunteers in each level will be infused 2, 4, 8, or 12 g of vehicle over 7 consecutive days: BID within 30 minutes for the first 6 days and QD on the 7th day.
干预措施: Vehicle (Drug)
结局指标
主要结局
Number of participants who experience treatment-related adverse events (AEs) and serious adverse events (SAEs)
时间窗: Day 0 to Day 11
Any untoward medical events during this study were categorized as severe, moderate, or mild, and related or not related to study treatment.
次要结局
- Plasma Concentration of YC-6(Day 0 to Day 8)