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
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Number of reported Adverse Events
研究概览
简要总结
This study is a randomized, double-blind, propofol position-controlled trial, evaluating the safety, tolerability, and pharmacodynamic of continuous infusion of KL0011034 injection compared with propofol injectable emulsion for durations of 1 hour, 2 hours, and 3 hours, and evaluating the pharmacokinetic of the KL0011034 injection.
详细描述
This study is a randomized, double-blind, active-controlled, continuous-infusion trial. It is planned to enroll 30 healthy subjects, who will be divided into three continuous-infusion groups (Groups 1 to 3), with 10 subjects per group. Block randomization will be used to assign subjects in a 4:1 ratio to either the test drug group or the active control group. In the test drug group, subjects will receive propofol injectable emulsion 2 mg/kg during the anesthesia induction phase, followed by KL0011034 injection during the anesthesia maintenance phase. In the active control group, subjects will receive propofol injectable emulsion 2 mg/kg during induction and propofol emulsion injection during maintenance. The maintenance durations for Groups 1, 2, and 3 are 1 hour (+5 min), 2 hours (+5 min), and 3 hours (+5 min), respectively. During the study, subjects will undergo assessments of safety, tolerability, and pharmacodynamics, and blood samples will be collected for pharmacokinetic analysis.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •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.
排除标准
- •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.
研究组 & 干预措施
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).
干预措施: propofol injectable emulsion (Drug)
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).
干预措施: KL0011034 injection (Drug)
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).
干预措施: KL0011034 injection (Drug)
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).
干预措施: KL0011034 injection (Drug)
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).
干预措施: propofol injectable emulsion (Drug)
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).
干预措施: propofol injectable emulsion (Drug)
结局指标
主要结局
Number of reported Adverse Events
时间窗: 24 hours post-dose
Safety and tolerability was assessed by the number of volunteers with adverse events.
次要结局
- PK parameter Cmax in plasma(24 hours post-dose)
- PK parameter Tmax in plasma(24 hours post-dose)
- PK parameter AUC0-∞ in plasma(24 hours post-dose)
- PK parameter AUC0-t in plasma(24 hours post-dose)
- PK parameter t1/2 in plasma(24 hours post-dose)
- Modified Observer's Assessment of Alertness Sedation (MOAA/S) scale(Day 1)
- Electroencephalogram bispectrality index (BIS) monitoring(Day 1)
- Modified Aldrete Scoring (Aldrete) Scale(Day 1)
- Post-Anesthetic Discharge Scoring System(Day 1)
- The time of complete awakening(Day 1)
- Mini-Mental State Examination(Day 1)
- Anesthesia satisfaction(Day 1)