NCT03773835已完成1 期
A Single-center, Open-label, Uncontrolled, and Dose-escalation Study Evaluating Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of Single IV Dose of HSK3486 Injectable Emulsion in Healthy Subjects.
Sichuan Haisco Pharmaceutical Group Co., Ltd0 个研究点目标入组 24 人开始时间: 2016年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 主要终点
- Safety by measurement of Adverse Events
研究概览
简要总结
his single-center, open-label, uncontrolled, and dose-escalation study evaluated the safety, tolerability, and pharmacokinetics/pharmacodynamics of single IV dose of HSK3486 injectable emulsion in healthy subjects.
研究设计
- 研究类型
- Interventional
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males or females with full capacity for civil conduct, between 18 and 49 years old (inclusive);
- •Body weight > 45 kg, and body mass index (BMI) ≥ 19 and ≤24 kg/m2;
- •Blood pressure between 90-140/60-90 mmHg; heart rate between 60-99 bpm; body temperature between 35.8-37.5 ºC; respiration rate between 12-24 breaths per minute; SpO2 when inhaling > 95%;
- •Normal physical examination, laboratory tests (blood routine, blood biochemistry, and urine routine), 12-Led ECG, posteroanterior and lateral chest x-ray, and or abnormal but without clinical significance (determined by investigator); no potential difficult airway;
- •Subjects must understand the procedures and methods of this study, and be willing to provide informed consent and to complete the trial in strict accordance with clinical trial protocol.
排除标准
- •Known sensitivity to propofol, excipient in propofol medium and long chain fat emulsion injection, excipient in HSK3486 injectable emulsion;
- •contraindicated in general anesthesia;
- •Received any one of the following medications or treatments prior to screening/enrollment:
- •History of medication abuse or any signs of chronic benzodiazepines use (such as insomnia, anxiety, spasms) within 3 months prior to screening, or a positive urine medication test (during screening or at baseline);
- •Participated in clinical trials involving any medications or medical devices within 3 months prior to screening, or participated in 3 or more drug clinical trials within the past year;
- •History or evidence of increased risk of sedation or anesthesia, such as cardiovascular disease, respiratory disease, cerebrovascular disease, gastrodintestinal disease and other system disease prior to the screening and/or baseline period;
- •Laboratory results that meet any of the following during screening/enrollment:
- •Positive for HBsAg, HCV, or HIV;
- •Abnormal hepatic or renal function confirmed after re-examination;
- •ALT or AST > ULN;
- •Creatinine > ULN;
- •History of smoking for more than 3 weeks and/or respiratory irritation caused by smoking within 3 months prior to screening;
- •History of alcohol abuse within 3 months prior to screening or a positive alcohol test (baseline);
- •Women who are pregnant or breastfeeding; women of child-bearing potential or men who are unwilling to use contraception during the trial;
- •Subjects judged by the investigator to be unsuitable for participating in this trial for any reason.
研究组 & 干预措施
HSK3486
Experimental
0.15mg/kg, 0.40mg/kg, 0.60mg/kg, 0.90mg/kg,
干预措施: HSK3486 (Drug)
结局指标
主要结局
Safety by measurement of Adverse Events
时间窗: First dose of study drug on day 1
Apnea
时间窗: First dose of study drug on day 1
No movement of chest wall and cessation of end-tidal carbon dioxide waveform \> 15 seconds.
次要结局
- Modified observer's assessment of alertness/sedation（MOAA/S）(From first dose of study drug until fully alert on day 1)
- Time to plasma peak concentration(Tmax)(From the start of administration to 48 hours after administration)
- Mean residence time (MRT)(From the start of administration to 48 hours after administration)
- Total clearance (CL)(From the start of administration to 48 hours after administration)
- Bispectral index （BIS）(From first dose of study drug until fully alert on day 1)
- Median effective dose (ED50)(From first dose of study drug until fully alert on day 1)
- Peak concentration (Cmax)(From the start of administration to 48 hours after administration)
- Area Under the Curve (AUC0-30min, AUC0-1h, AUC0-last, and AUC0-inf)(From the start of administration to 48 hours after administration)
- Terminal elimination half life (t1/2z) and mean residence time (MRT)(From the start of administration to 48 hours after administration)
研究者
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