Healthy Volunteers
Conditions
Keywords
Healthy
Brief summary
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.
Detailed description
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.
Interventions
Intravenous injection, continuous infusion
Intravenous injection, continuous infusion
Sponsors
Hunan Kelun Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Sign the informed consent form 2. Health participants (Age: 18\~45 years); 3. Body Weight: Male≥50.0kg, Female≥45.0kg; 19 ≤BMI≤ 26.0kg/m2; 4. There were no abnormalities in clinically significant physical examination, vital signs, 12-lead electrocardiogram, chest x-ray, abdominal B-ultrasound, laboratory tests; 5. Agreed to use contraception for 3 months post-dose.
Exclusion criteria
1. Allergy or Drug hypersensitivity; 2. Clinically significant Medical History; 3. History of anesthesia accident, history of serious adverse reactions of anesthesia, or family history of anesthesia accidents, or contraindications to general anesthesia; 4. Dyspnoea or suspected difficult airway, or predicting difficult endotracheal intubation; 5. History of bronchial asthma, chronic obstructive pulmonary disease, sleep apnea syndrome; 6. History of adrenal insufficiency or adrenal tumor or hereditary heme biosynthesis disorder or hereditary acute porphyria; 7. History of any surgery within 3 months; 8. History of any Medication within 14 days; 9. History of any clinical study within 3 months; 10. History of any vaccine within 1 month; 11. History of any drug abuse; 12. Needle sickness, Hematosickness; 13. Massive blood loss (\> 400 mL) in the past 3 months; 14. Female volunteers are pregnant or lactating; 15. History of unprotected sex within 2 weeks; 16. Heavy smoker ( more than 5 cigarettes/day) within 3 months; 17. History of alcohol abuse,or heavy alcohol intake (more than 14 units a week) within 6 months; 18. Heavy caffeine intake; 19. History of grapefruit, xanthine-rich foods intake within 48 hours; 20. Positive alcohol test; 21. Positive nicotine test; 22. Positive drugs of abuse test result.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of reported Adverse Events | 24 hours post-dose | Safety and tolerability was assessed by the number of volunteers with adverse events. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PK parameter Cmax in plasma | 24 hours post-dose | Maximum peak plasma concentration (Cmax) of KL0011034 and its metabolite |
| PK parameter Tmax in plasma | 24 hours post-dose | Time of Cmax (Tmax) of KL0011034 and its metabolite |
| PK parameter AUC0-t in plasma | 24 hours post-dose | Area under the concentration-time curve (AUC0-t) from time zero to time "t" of KL0011034 and its metabolite |
| PK parameter AUC0-∞ in plasma | 24 hours post-dose | AUC from time zero to infinity (AUC0-∞) of KL0011034 and its metabolite |
| PK parameter t1/2 in plasma | 24 hours post-dose | Terminal-phase elimination half-life (t1/2) of KL0011034 and its metabolite |
| Modified Observer's Assessment of Alertness Sedation (MOAA/S) scale | Day 1 | 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. |
| Electroencephalogram bispectrality index (BIS) monitoring | Day 1 | 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. |
| Modified Aldrete Scoring (Aldrete) Scale | Day 1 | 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. |
| Post-Anesthetic Discharge Scoring System | Day 1 | 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. |
| The time of complete awakening | Day 1 | 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. |
| Mini-Mental State Examination | Day 1 | 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. |
| Anesthesia satisfaction | Day 1 | 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. |
Countries
China
Contacts
CONTACTWei Qi
Outcome results
None listed