NCT04197661已完成1 期
A Study Evaluating Pharmacokinetics, Pharmacodynamics and Safety of Intravenous Administration of HSK3486 Injectable Emulsion in Healthy Elderly Subjects
Sichuan Haisco Pharmaceutical Group Co., Ltd1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2019年12月25日最近更新:
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
- 32
- 试验地点
- 1
- 主要终点
- Peak concentration (Cmax)
研究概览
简要总结
It is a single-center, open-label, dose-finding, Phase I clinical study evaluating the pharmacokinetics, pharmacodynamics, and safety characteristics of HSK3486 in healthy elderly subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Sign the informed consent form and fully understand the content, procedure and possible adverse effects before the trial starts;
- •Able to complete the study in compliance with the requirements of the clinical trial protocol;
- •Subjects (including their partners) are willing to voluntarily adopt an effective measure of contraception starting from screening to 6 months after the last dose of the investigational drug. See the attachment for specific contraceptive measures;
- •Males and females with full capacity for civil conduct, aged ≥ 18 years old (aged between 18 and 64 years old for the non-elderly group and ≥ 65 years old for the elderly group (inclusive));
- •Females weighing ≥ 45 kg and males weighing ≥ 50 kg, and with a body mass index (BMI) of ≥ 18 and ≤ 30 kg/m2 (BMI = Weight (kg)/height2(m2))(inclusive);
- •For all subjects, the body temperature should be between 35.9-37.6 °C, respiratory rate between 12-20 breaths/min, and SpO2 when inhaling > 95%; in addition, for subjects in the non-elderly group, the blood pressure should be between 90-140/60-90 mmHg and heart rate between 60-99 bpm; for those in the elderly group, the blood pressure should be between 90-160/60-100 mmHg and heart rate between 50-100 bpm;
排除标准
- •Smoke more than 5 cigarettes per day on average within 3 months prior to screening;
- •Patient having contraindications to deep sedation/general anesthesia or a history of past sedation/anesthesia accidents;
- •Known sensitivity to HSK3486 excipients (soybean oil, glycerin, triglyceride, egg lecithin, sodium oleate, and sodium hydroxide); or history of drug allergies (including other anesthetics), allergic diseases, or those with hyperactive immuneresponse(allergies to various drugs and foods);
- •History of drug abuse or any signs of long-term use of benzodiazepines (such as insomnia, anxiety, spasms) within 3 months prior to screening;
- •Acute diseases with clinical significance (determined by the investigator) within 2 weeks prior to screening, including GI diseases and infections (such as respiratory or CNS infections);
- •History or evidence of cardiovascular diseases prior to screening: Uncontrolled hypertension [SBP ≥ 170 mmHg and/or DBP ≥ 105 mmHg without antihypertensive treatment, or SBP > 160 mmHg and/or DBP > 100 mmHg despite antihypertensive treatment], postural hypotension, severe arrhythmia, heart failure, Adams-Stokes syndrome, unstable angina, myocardial infarction within 6 months before screening, history of tachycardia/bradycardia requiring medication, II-III degree atrioventricular block (excluding patients with pacemakers), or QTcF interval ≥ 450 ms (Fridericia's correction formula);
- •Subjects judged by the investigator to be unsuitable for participating in this trial for any reason.
研究组 & 干预措施
Elderly group Ⅲ
Active Comparator
Elderly group Ⅲ 65 years or older 0.4 mg/kg HSK3486
干预措施: HSK3486 (Drug)
Elderly groupⅠ
Active Comparator
Elderly groupⅠ 65 years or older 0.2 mg/kg HSK3486
干预措施: HSK3486 (Drug)
Elderly group Ⅱ
Active Comparator
Elderly group Ⅱ 65 years or older 0.3 mg/kg HSK3486
干预措施: HSK3486 (Drug)
Non-elderly group IV
Active Comparator
Non-elderly group IV 18 to 64 years 0.4 mg/kg HSK3486
干预措施: HSK3486 (Drug)
结局指标
主要结局
Peak concentration (Cmax)
时间窗: -30 minutes before administration until 24 hours post administration on day 1
Cmax（a measure of the body's exposure to HSK3486）will be compared between non-elderly subjects and elderly subjects.
Area under the concentration-time curve（AUC）
时间窗: -30 minutes before administration until 24 hours post administration on day 1
AUC（a measure of the body's exposure to HSK3486）will be compared between non-elderly subjects and elderly subjects.
次要结局
- Total clearance(-30 minutes before administration until 24 hours post administration on day 1)
- MOAA/S(modified observer's assessment of alert /sedation)(-5 minutes before administration until 1 hours post administration on day 1)
- Bispectral index(BIS)(-5 minutes before administration until 1 hours post administration on day 1)
- Tmax(-30 minutes before administration until 24 hours post administration on day 1)
- blood pressure（systolic, diastolic and mean arterial pressure）(from the screening to 2 days post-dose)
研究者
研究点 (1)
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