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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: KL0011034 injection; Drug: propofol injectable emulsion

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Wei Qi; Phone Number: 028-82339360; Email: qiw@kelun.com

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410205
      • The Third XIANGYA Hospital of Central South University
      • Contact: Guoping Yang; Phone Number: 13974817168; Email: ygp9880@163.com
      • Contact: Saiying Wang; Phone Number: 0731-88618150; Email: 1771303488@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Drug: KL0011034 injection; Intravenous injection, continuous infusion; Drug: propofol injectable emulsion; Intravenous injection, continuous infusion
Experimental: 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).	Drug: KL0011034 injection; Intravenous injection, continuous infusion; Drug: propofol injectable emulsion; Intravenous injection, continuous infusion
Experimental: 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).	Drug: KL0011034 injection; Intravenous injection, continuous infusion; Drug: propofol injectable emulsion; Intravenous injection, continuous infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of reported Adverse Events	Safety and tolerability was assessed by the number of volunteers with adverse events.	24 hours post-dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PK parameter Cmax in plasma	Maximum peak plasma concentration (Cmax) of KL0011034 and its metabolite	24 hours post-dose
PK parameter Tmax in plasma	Time of Cmax (Tmax) of KL0011034 and its metabolite	24 hours post-dose
PK parameter AUC0-t in plasma	Area under the concentration-time curve (AUC0-t) from time zero to time "t" of KL0011034 and its metabolite	24 hours post-dose
PK parameter AUC0-∞ in plasma	AUC from time zero to infinity (AUC0-∞) of KL0011034 and its metabolite	24 hours post-dose
PK parameter t1/2 in plasma	Terminal-phase elimination half-life (t1/2) of KL0011034 and its metabolite	24 hours post-dose
Modified Observer's Assessment of Alertness Sedation (MOAA/S) scale	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.	Day 1
Electroencephalogram bispectrality index (BIS) monitoring	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.	Day 1
Modified Aldrete Scoring (Aldrete) Scale	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.	Day 1
Post-Anesthetic Discharge Scoring System	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.	Day 1
The time of complete awakening	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.	Day 1
Mini-Mental State Examination	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.	Day 1
Anesthesia satisfaction	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

Collaborators and Investigators

• Sponsor: Hunan Kelun Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): October 13, 2026
• Primary Completion (Estimated): November 13, 2026
• Study Completion (Estimated): November 13, 2026

Study Registration Dates

• First Submitted: September 11, 2026
• First Submitted That Met QC Criteria: September 17, 2026
• First Posted (Actual): September 18, 2026

Study Record Updates

• Last Update Posted (Actual): September 18, 2026
• Last Update Submitted That Met QC Criteria: September 17, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: Healthy
• Other Study ID Numbers: KL0011034-103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No