A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of KL0011034 Injection Administered by Continuous Infusion in Healthy Adult Subjects
A Single-center, Randomized, Double-blind, Propofol Position-controlled Phase I Clinical Study Evaluating the Safety, Pharmacokinetics/Pharmacodynamics of KL0011034 Injection by Continuous Infusion in Healthy Chinese Adult Subjects
研究概览
详细说明
研究类型
注册 (估计的)
阶段
- 阶段1
联系人和位置
学习联系方式
- 姓名:Wei Qi
- 电话号码:028-82339360
- 邮箱:qiw@kelun.com
学习地点
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Hunan
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Changsha、Hunan、中国、410205
- The Third XIANGYA Hospital of Central South University
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接触:
- Guoping Yang
- 电话号码:13974817168
- 邮箱:ygp9880@163.com
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接触:
- Saiying Wang
- 电话号码:0731-88618150
- 邮箱:1771303488@qq.com
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参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
描述
Inclusion Criteria:
- Sign the informed consent form
- Health participants (Age: 18~45 years);
- Body Weight: Male≥50.0kg, Female≥45.0kg; 19 ≤BMI≤ 26.0kg/m2;
- There were no abnormalities in clinically significant physical examination, vital signs, 12-lead electrocardiogram, chest x-ray, abdominal B-ultrasound, laboratory tests;
- Agreed to use contraception for 3 months post-dose.
Exclusion Criteria:
- Allergy or Drug hypersensitivity;
- Clinically significant Medical History;
- History of anesthesia accident, history of serious adverse reactions of anesthesia, or family history of anesthesia accidents, or contraindications to general anesthesia;
- Dyspnoea or suspected difficult airway, or predicting difficult endotracheal intubation;
- History of bronchial asthma, chronic obstructive pulmonary disease, sleep apnea syndrome;
- History of adrenal insufficiency or adrenal tumor or hereditary heme biosynthesis disorder or hereditary acute porphyria;
- History of any surgery within 3 months;
- History of any Medication within 14 days;
- History of any clinical study within 3 months;
- History of any vaccine within 1 month;
- History of any drug abuse;
- Needle sickness, Hematosickness;
- Massive blood loss (> 400 mL) in the past 3 months;
- Female volunteers are pregnant or lactating;
- History of unprotected sex within 2 weeks;
- Heavy smoker ( more than 5 cigarettes/day) within 3 months;
- History of alcohol abuse,or heavy alcohol intake (more than 14 units a week) within 6 months;
- Heavy caffeine intake;
- History of grapefruit, xanthine-rich foods intake within 48 hours;
- Positive alcohol test;
- Positive nicotine test;
- Positive drugs of abuse test result.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Low-dose group
subjects will receive propofol injectable emulsion 2 mg/kg during the anesthesia induction phase, followed by KL0011034 injection or propofol injectable emulsion during the anesthesia maintenance phase.
The maintenance durations for low-dose group is 1 hour (+5 min).
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Intravenous injection, continuous infusion
Intravenous injection, continuous infusion
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实验性的:Medium-dose group
subjects will receive propofol injectable emulsion 2 mg/kg during the anesthesia induction phase, followed by KL0011034 injection or propofol injectable emulsion during the anesthesia maintenance phase.
The maintenance durations for medium-dose group is 2 hours (+5 min).
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Intravenous injection, continuous infusion
Intravenous injection, continuous infusion
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实验性的:High-dose group
subjects will receive propofol injectable emulsion 2 mg/kg during the anesthesia induction phase, followed by KL0011034 injection or propofol injectable emulsion during the anesthesia maintenance phase.
The maintenance durations for high-dose group is 3 hours (+5 min).
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Intravenous injection, continuous infusion
Intravenous injection, continuous infusion
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of reported Adverse Events
大体时间:24 hours post-dose
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Safety and tolerability was assessed by the number of volunteers with adverse events.
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24 hours post-dose
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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PK parameter Cmax in plasma
大体时间:24 hours post-dose
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Maximum peak plasma concentration (Cmax) of KL0011034 and its metabolite
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24 hours post-dose
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PK parameter Tmax in plasma
大体时间:24 hours post-dose
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Time of Cmax (Tmax) of KL0011034 and its metabolite
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24 hours post-dose
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PK parameter AUC0-t in plasma
大体时间:24 hours post-dose
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Area under the concentration-time curve (AUC0-t) from time zero to time "t" of KL0011034 and its metabolite
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24 hours post-dose
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PK parameter AUC0-∞ in plasma
大体时间:24 hours post-dose
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AUC from time zero to infinity (AUC0-∞) of KL0011034 and its metabolite
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24 hours post-dose
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PK parameter t1/2 in plasma
大体时间:24 hours post-dose
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Terminal-phase elimination half-life (t1/2) of KL0011034 and its metabolite
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24 hours post-dose
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Modified Observer's Assessment of Alertness Sedation (MOAA/S) scale
大体时间:Day 1
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MOAA/S is a commonly used clinical sedation assessment scale, ranging from 0 to 5, which helps clinicians determine the level of sedation in patients.
A score of 5 indicates full consciousness, whereas a score of 0 indicates deep coma.
Lower scores correspond to deeper levels of sedation.
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Day 1
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Electroencephalogram bispectrality index (BIS) monitoring
大体时间:Day 1
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BIS is the most widely used method for the continuous monitoring of sedation depth in clinical anesthesia.
BIS values range from 0 to 100, where 100 represents complete wakefulness and 0 indicates complete cortical electrical inhibition.
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Day 1
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Modified Aldrete Scoring (Aldrete) Scale
大体时间:Day 1
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The Modified Aldrete Score is the most widely used standardized tool for assessing discharge readiness from post-anesthesia care unit (PACU).
It evaluates five parameters: activity, respiration, blood pressure consciousness, and SpO₂.
Ranging from 0 to 10, the higher the score, the better the quality of recovery.
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Day 1
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Post-Anesthetic Discharge Scoring System
大体时间:Day 1
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PADSS assesses based on five dimensions: vital signs, activity status, nausea and vomiting, pain severity, and surgical bleeding.
Each item is scored from 0 to 2, with a total score of 10, the higher the score, the better the quality of recovery.
Discharge can be arranged when the score reaches 9.
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Day 1
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The time of complete awakening
大体时间:Day 1
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The definition of complete awakening is that the MOAA/S score is 5 for three consecutive times.
The time point when the first score among the three consecutive times is 5 is the time point of complete awakening.
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Day 1
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Mini-Mental State Examination
大体时间:Day 1
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The quality of awakening was evaluated through the "orientation in the recovery period" and "memory" sections of the MMSE scale.
The "orientation in the recovery period" assesses based on 10 questions, each question is scored from 0 to 1, with a total score of 10.
The "memory" assesses based on 3 questions, including the repetition of 6 different things and performing 5 subtraction calculations, with a total score of 11. the higher the score, the better the quality of awakening.
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Day 1
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Anesthesia satisfaction
大体时间:Day 1
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satisfaction of anesthesiologists and satisfaction of patients. The "satisfaction of patients" assesses based on 2 parts, with a total score of 150. the higher the score, the better the quality of recovery. Part A: How do you feeling in the past 24 hours ( including 10 questions, each question is scored from 0 to 10, with a total score of 100 ). Part B: Have you experienced following 5 situations in the past 24 hours ( each situation is scored from 0 to 10, with a total score of 50 ). The " satisfaction of anesthesiologists" assesses based on 2 dimensions: Maintaining hemodynamic stability during the maintenance period, and Awakening status (whether agitated, choking, or coughing). Each item is scored from 1 to 5, with a total score of 10, the higher the score, the better the quality of recovery. |
Day 1
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- KL0011034-103
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
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