AzTrials
AzTrials

Healthy Participants StudyPhase 1NCT07841626

Safety, Pharmacokinetics, and Pharmacodynamics of Continuous KL0011034 Infusion in Healthy Chinese Adults

A Phase 1 study testing KL0011034 Injection and Propofol Injectable Emulsion in people with Healthy Participants Study and General Anesthesia, run by The Third Xiangya Hospital of Central South University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This Phase 1 study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of continuous intravenous infusion of KL0011034 Injection in healthy Chinese adults. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
What is being tested?
KL0011034 Injection and Propofol Injectable Emulsion
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
No sites listed yet
Study dates
6 Nov 2026to 5 Sep 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Participants who fully understand the purpose, content, procedures, and possible risks of the study, voluntarily agree to participate, and sign the informed consent form.
  • Healthy male or female participants aged 18 to 45 years, inclusive, at the time of informed consent.
  • Body weight ≥50.0 kg for males and ≥45.0 kg for females; body mass index 19.0 to 26.0 kg/m², inclusive.
  • From informed consent through 3 months after completion of study-drug infusion, the participant and partner have no reproductive plans and the participant has no sperm or egg donation plans; the participant agrees to use at least one non-pharmacologic contraceptive method through the last pharmacokinetic sample and effective contraception through 3 months after infusion.
  • Able to communicate well with the investigator and willing and able to comply with protocol-specified lifestyle restrictions and complete study procedures.

Who cannot join

  • Known allergy to etomidate, propofol, or other anesthetic drugs; allergic constitution (for example, allergy to two or more drugs, foods, or pollen); tendency to rash or urticaria; history of allergic disease; or known allergy to the active ingredient or excipients of KL0011034 Injection.
  • History of clinically significant cardiovascular, endocrine, respiratory, gastrointestinal, urinary, neurologic, hematologic, lymphatic, or psychiatric disease that remains clinically significant at screening in the investigator's judgment.
  • History of anesthesia accident, serious anesthesia-related adverse reaction, or family history of anesthesia accident.
  • Difficult ventilation, suspected difficult airway, or anticipated difficult tracheal intubation, including Modified Mallampati Class III-IV, congenital small mouth with macroglossia, mandibular hypoplasia, or similar findings.
  • History of airway disease before or at screening, including bronchial asthma, chronic obstructive pulmonary disease, or sleep apnea syndrome.
  • History of adrenocortical insufficiency, adrenal tumor, hereditary disorder of heme biosynthesis, or hereditary acute porphyria.
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  • Clinically significant abnormal findings in physical examination, vital signs, posteroanterior chest radiograph, abdominal ultrasonography, hematology, urinalysis, blood chemistry, coagulation, or infectious-disease screening; or clinically significant abnormal overall circadian pattern of cortisol and/or ACTH at screening in the investigator's judgment.
  • Clinically significant electrocardiogram abnormality at screening, including QTcF ≥450 ms in males or ≥460 ms in females.
  • Pregnant or breastfeeding female, or a woman of childbearing potential with a positive pregnancy test during screening.
  • Unprotected sexual intercourse within 2 weeks before dosing.
  • History of drug abuse or drug dependence within 1 year before screening, or positive urine drug screen at screening.
  • History of alcohol abuse within 6 months before screening, defined as more than 14 standard units per week (1 unit = 360 mL beer, 45 mL of 40% spirits, or 150 mL wine); positive breath alcohol test; or unwillingness to abstain from alcohol and alcohol-containing products during the study.
  • Smoking ≥5 cigarettes per day within 6 months before screening; unwillingness to stop using tobacco products during the study; or positive smoking test at screening.
  • Habitual consumption of more than 8 cups per day (1 cup = 250 mL) of tea, coffee, or caffeine-containing beverages, or unwillingness to abstain from these beverages during the study.
  • Consumption of grapefruit-rich foods or beverages within 48 hours before first dosing.
  • Use of any prescription drug, over-the-counter drug, traditional Chinese medicine, health supplement, or vitamin within 14 days before screening; or use of sedative/analgesic or other anesthetic drugs within 5 days before first dosing.
  • Participation in any clinical trial within 3 months before dosing, or still in the follow-up period of another trial.
  • Receipt of an inactivated vaccine within 1 month before screening or a live/attenuated vaccine within 3 months before screening, or planned vaccination during the study.
  • Blood loss, blood donation, blood transfusion, or receipt of blood products totaling more than 400 mL within 3 months before screening; or planned blood donation or surgery during the study or within 1 month after study completion.
  • Surgery within 3 months before screening, incomplete recovery from surgery, or planned surgery during the study.
  • Special dietary requirements incompatible with standardized meals, swallowing difficulty, habitual anorexia or dieting, or initiation of a markedly abnormal diet (for example, a restrictive or low-sodium diet) within 4 weeks before screening.
  • Difficult venous access, inability to tolerate venipuncture, or history of fainting in response to blood or needles.
  • Expected poor compliance or any other condition that, in the investigator's judgment, makes the participant unsuitable for the study.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Jie Huang contact

+86 731 8991 8665

cellahuang1988@163.com

About this study

Official title: A Single-Center, Randomized, Double-Blind, Active-Controlled Phase 1 Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Continuous Infusion of KL0011034 Injection in Healthy Chinese Adults

This Phase 1 study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of continuous intravenous infusion of KL0011034 Injection in healthy Chinese adults. Approximately 30 participants will be enrolled in three sequential infusion-duration cohorts (1, 2, and 3 hours; 10 participants per cohort). Within each cohort, participants will be randomized in a 4:1 ratio to KL0011034 Injection or active-control propofol for anesthesia maintenance. All participants will receive propofol 2 mg/kg for anesthesia induction. Safety, pharmacokinetic, pharmacodynamic, recovery, and anesthesia-satisfaction assessments will be performed through 24 hours after dosing. Progression to the next infusion-duration cohort will occur only after the preceding cohort is considered safe and tolerable.

Read the detailed description

This is a single-center, randomized, blinded, active-controlled Phase 1 study in 30 healthy Chinese adults. The study contains three sequential cohorts defined by anesthesia-maintenance duration: 1 hour, 2 hours, and 3 hours. Each cohort will enroll approximately 10 participants. Within each cohort, participants will be randomized 4:1 to the investigational-maintenance regimen or the active-control-maintenance regimen.

All participants will receive propofol injectable emulsion 2 mg/kg intravenously over 1 minute (±5 seconds) for anesthesia induction. Maintenance infusion will begin within 30 seconds after induction. Participants assigned to the investigational regimen will receive KL0011034 Injection at a recommended maintenance rate of 1.1 mg/kg/hour; the rate may be adjusted by the investigator to maintain a bispectral index (BIS) of 40 to 60 and must not exceed the protocol-defined upper limit. Participants assigned to the active comparator will receive propofol injectable emulsion at a suggested rate of 4 to 12 mg/kg/hour, adjustable to maintain BIS at 40 to 60.

The 1-hour cohort will be evaluated before the 2-hour cohort begins, and the 2-hour cohort will be evaluated before the 3-hour cohort begins. Progression requires review confirming acceptable safety and tolerability. Participants will undergo safety monitoring, serial plasma sampling for noncompartmental pharmacokinetic analysis, and pharmacodynamic and recovery assessments including MOAA/S, BIS, Modified Aldrete Score, PADSS, recovery quality, and anesthesia satisfaction. The study includes screening, a 1-day baseline period, and approximately 24 hours of post-dose observation.

Being tested
KL0011034 Injection, Propofol Injectable Emulsion
Keywords
KL0011034, Continuous Intravenous Infusion, General Anesthesia, Pharmacokinetics, Pharmacodynamics, Bispectral Index, Healthy Participants

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KL0011034 InjectionDrug

    Intravenous maintenance infusion at a recommended rate of 1.1 mg/kg/hour for 1, 2, or 3 hours according to assigned cohort. The investigator may adjust the rate to maintain BIS 40-60; any upward adjustment must remain within the protocol-defined maximum rate of 2.5 mg/kg/hour.

  • Propofol Injectable EmulsionDrug

    All participants receive 2 mg/kg intravenously over 1 minute (±5 seconds) for anesthesia induction. In active-comparator arms, maintenance propofol is infused at a suggested rate of 4-12 mg/kg/hour for 1, 2, or 3 hours according to assigned cohort, adjustable to maintain BIS 40-60.

Study groups in NCT07841626
Study groupRoleWhat they receive
Cohort 1: KL0011034, 1-Hour InfusionExperimentalParticipants receive propofol injectable emulsion 2 mg/kg IV for induction, followed by KL0011034 Injection at a recommended maintenance rate of 1.1 mg/kg/hour for 1 hour. The rate may be adjusted to maintain BIS 40-60 within protocol limits.
Receives: Drug: KL0011034 Injection
Cohort 1: Propofol, 1-Hour InfusionActive comparatorParticipants receive propofol injectable emulsion 2 mg/kg IV for induction, followed by propofol injectable emulsion at 4-12 mg/kg/hour for 1 hour. The rate may be adjusted to maintain BIS 40-60.
Receives: Drug: Propofol Injectable Emulsion
Cohort 2: KL0011034, 2-Hour InfusionExperimentalParticipants receive propofol injectable emulsion 2 mg/kg IV for induction, followed by KL0011034 Injection at a recommended maintenance rate of 1.1 mg/kg/hour for 2 hours. The rate may be adjusted to maintain BIS 40-60 within protocol limits.
Receives: Drug: KL0011034 Injection
Cohort 2: Propofol, 2-Hour InfusionActive comparatorParticipants receive propofol injectable emulsion 2 mg/kg IV for induction, followed by propofol injectable emulsion at 4-12 mg/kg/hour for 2 hours. The rate may be adjusted to maintain BIS 40-60.
Receives: Drug: Propofol Injectable Emulsion
Cohort 3: KL0011034, 3-Hour InfusionExperimentalParticipants receive propofol injectable emulsion 2 mg/kg IV for induction, followed by KL0011034 Injection at a recommended maintenance rate of 1.1 mg/kg/hour for 3 hours. The rate may be adjusted to maintain BIS 40-60 within protocol limits.
Receives: Drug: KL0011034 Injection
Cohort 3: Propofol, 3-Hour InfusionActive comparatorParticipants receive propofol injectable emulsion 2 mg/kg IV for induction, followed by propofol injectable emulsion at 4-12 mg/kg/hour for 3 hours. The rate may be adjusted to maintain BIS 40-60.
Receives: Drug: Propofol Injectable Emulsion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse Events and Serious Adverse Events

    Incidence, severity, seriousness, relationship, and outcome of adverse events and serious adverse events.

    Measured: From informed consent through Day 2 discharge/early termination; unresolved adverse events are followed as specified in the protocol.

  2. Physical Examination Findings

    Number of participants with clinically significant changes or abnormalities in physical examination findings.

    Measured: Screening, Day -2 as applicable, Day -1, Day 2/end-of-study, and early termination.

  3. Holter Monitoring Findings

    Clinically significant abnormalities detected by protocol-specified Holter monitoring.

    Measured: Time-matched baseline on Day -1; Day 1 from infusion start through 24 hours after infusion at protocol-specified time points (infusion start; 30 minutes, 1, 2, 3 hours after start; 2, 10, 30 minutes, 1, 4, 12, 24 hours after completion).

  4. Plasma Cortisol Concentration

    Plasma cortisol concentration (measured in nmol/L) assessed by protocol-specified laboratory testing.

    Measured: Screening (Day -14 to Day -2) at 07:00-08:00, 16:00 , and 00:00; time-matched baseline on Day -1; on Day 1, pre-dose, at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, and 8 hours after infusion start, and at 16:00 and 00:00; and on Day 2 at 08:00.

  5. Plasma Adrenocorticotropic Hormone Concentration

    Plasma adrenocorticotropic hormone (ACTH) concentration (measured in pg/mL) assessed by protocol-specified laboratory testing.

    Measured: Screening (Day -14 to Day -2) at 07:00-08:00, 16:00 , and 00:00; time-matched baseline on Day -1; on Day 1, pre-dose, at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, and 8 hours after infusion start, and at 16:00 and 00:00; and on Day 2 at 08:00.

  6. Blood Pressure

    Change from baseline in blood pressure (systolic and diastolic, measured in mmHg) assessed by standard vital sign measurement.

    Measured: Day 1: pre-dose; during infusion at 30 minutes, 1, 2, 3 hours; post-infusion at 30 minutes, 1, 2, 4, 8, 12, 24 hours; and at early termination.

  7. Pulse Rate

    Change from baseline in pulse rate (measured in beats per minute) assessed by standard vital sign measurement.

    Measured: Day 1: pre-dose; during infusion at 30 minutes, 1, 2, 3 hours; post-infusion at 30 minutes, 1, 2, 4, 8, 12, 24 hours; and at early termination.

  8. Respiratory Rate

    Change from baseline in respiratory rate (measured in breaths per minute) assessed by standard vital sign measurement.

    Measured: Day 1: pre-dose; during infusion at 30 minutes, 1, 2, 3 hours; post-infusion at 30 minutes, 1, 2, 4, 8, 12, 24 hours; and at early termination.

  9. Body Temperature

    Change from baseline in tympanic body temperature (measured in degrees Celsius) assessed by standard vital sign measurement.

    Measured: Day 1: pre-dose; during infusion at 30 minutes, 1, 2, 3 hours; post-infusion at 30 minutes, 1, 2, 4, 8, 12, 24 hours; and at early termination.

  10. Oxygen Saturation (SpO2)

    Change from baseline in oxygen saturation (measured as percentage of oxygen saturation) assessed by pulse oximetry.

    Measured: Day 1: pre-dose; during infusion at 30 minutes, 1, 2, 3 hours; post-infusion at 30 minutes, 1, 2, 4, 8, 12, 24 hours; and at early termination.

  11. Heart Rate

    Change from baseline in heart rate (measured in beats per minute) assessed by 12-lead electrocardiogram.

    Measured: Pre-dose (within 1 hour before anesthesia induction); after completion of continuous infusion at 30 minutes (±5 minutes), 2 hours (±10 minutes), 4 hours (±10 minutes), 8 hours (±15 minutes), and 24 hours (±20 minutes); and at early termination.

  12. PR Interval

    Change from baseline in PR interval (measured in milliseconds) assessed by 12-lead electrocardiogram.

    Measured: Pre-dose (within 1 hour before anesthesia induction); after completion of continuous infusion at 30 minutes (±5 minutes), 2 hours (±10 minutes), 4 hours (±10 minutes), 8 hours (±15 minutes), and 24 hours (±20 minutes); and at early termination.

  13. Change From Time-Matched Baseline in Plasma Cortisol Concentration

    Change from time-matched baseline in plasma cortisol concentration (measured in nmol/L) assessed by protocol-specified laboratory testing.

    Measured: Screening (Day -14 to Day -2) at 07:00-08:00, 16:00 , and 00:00; time-matched baseline on Day -1; on Day 1, pre-dose, at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, and 8 hours after infusion start, and at 16:00 and 00:00; and on Day 2 at 08:00.

  14. QRS Interval

    Change from baseline in QRS interval (measured in milliseconds) assessed by 12-lead electrocardiogram.

    Measured: Pre-dose (within 1 hour before anesthesia induction); after completion of continuous infusion at 30 minutes (±5 minutes), 2 hours (±10 minutes), 4 hours (±10 minutes), 8 hours (±15 minutes), and 24 hours (±20 minutes); and at early termination.

  15. QT Interval

    Change from baseline in QT interval (measured in milliseconds) assessed by 12-lead electrocardiogram.

    Measured: Pre-dose (within 1 hour before anesthesia induction); after completion of continuous infusion at 30 minutes (±5 minutes), 2 hours (±10 minutes), 4 hours (±10 minutes), 8 hours (±15 minutes), and 24 hours (±20 minutes); and at early termination.

  16. QTcF Interval

    Change from baseline in QT interval corrected using Fridericia's formula (measured in milliseconds) assessed by 12-lead electrocardiogram.

    Measured: Pre-dose (within 1 hour before anesthesia induction); after completion of continuous infusion at 30 minutes (±5 minutes), 2 hours (±10 minutes), 4 hours (±10 minutes), 8 hours (±15 minutes), and 24 hours (±20 minutes); and at early termination.

  17. Change From Time-Matched Baseline in Plasma Adrenocorticotropic Hormone Concentration

    Change from time-matched baseline in plasma adrenocorticotropic hormone (ACTH) concentration (measured in pg/mL) assessed by protocol-specified laboratory testing.

    Measured: Screening (Day -14 to Day -2) at 07:00-08:00, 16:00 , and 00:00; time-matched baseline on Day -1; on Day 1, pre-dose, at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, and 8 hours after infusion start, and at 16:00 and 00:00; and on Day 2 at 08:00.

Secondary outcomes (48)

  1. Maximum Plasma Concentration (Cmax) of KL0011034

    Maximum observed plasma concentration.

    Measured: pre-induction and pre-maintenance; during infusion at 5, 10, 20, 30, and 45 minutes and 1, 2, or 3 hours as applicable; after infusion at 2, 5, 10, 20, 30, and 40 minutes and 1, 2, 4, 8, 12, and 24 hours.

  2. Time to Maximum Plasma Concentration (Tmax) of KL0011034

    Time of the first occurrence of the maximum observed plasma concentration.

    Measured: Pre-induction and pre-maintenance; during infusion at 5, 10, 20, 30, and 45 minutes and 1, 2, or 3 hours as applicable; after infusion at 2, 5, 10, 20, 30, and 40 minutes and 1, 2, 4, 8, 12, and 24 hours.

  3. Area Under the Curve From Time Zero to the Last Quantifiable Concentration (AUC0-t) of KL0011034

    Calculated using the linear-up/log-down trapezoidal method.

    Measured: Pre-induction and pre-maintenance; during infusion at 5, 10, 20, 30, and 45 minutes and 1, 2, or 3 hours as applicable; after infusion at 2, 5, 10, 20, 30, and 40 minutes and 1, 2, 4, 8, 12, and 24 hours.

  4. Area Under the Curve From Time Zero Extrapolated to Infinity (AUC0-∞) of KL0011034

    Calculated as AUC0-t + Clast/λz.

    Measured: Pre-induction and pre-maintenance; during infusion at 5, 10, 20, 30, and 45 minutes and 1, 2, or 3 hours as applicable; after infusion at 2, 5, 10, 20, 30, and 40 minutes and 1, 2, 4, 8, 12, and 24 hours.

  5. Area Under the Curve From Time Zero to 24 Hours (AUC0-24h) of KL0011034

    Calculated using the linear-up/log-down trapezoidal method.

    Measured: Pre-induction and pre-maintenance; during infusion at 5, 10, 20, 30, and 45 minutes and 1, 2, or 3 hours as applicable; after infusion at 2, 5, 10, 20, 30, and 40 minutes and 1, 2, 4, 8, 12, and 24 hours.

  6. Percentage of AUC Extrapolated to Infinity (AUC%Extrap) of KL0011034

    Calculated as [(AUC0-∞ - AUC0-t)/AUC0-∞] × 100%.

    Measured: Pre-induction and pre-maintenance; during infusion at 5, 10, 20, 30, and 45 minutes and 1, 2, or 3 hours as applicable; after infusion at 2, 5, 10, 20, 30, and 40 minutes and 1, 2, 4, 8, 12, and 24 hours.

  7. Clearance (CL) of KL0011034

    Calculated as Dose/AUC0-∞, as applicable.

    Measured: Pre-induction and pre-maintenance; during infusion at 5, 10, 20, 30, and 45 minutes and 1, 2, or 3 hours as applicable; after infusion at 2, 5, 10, 20, 30, and 40 minutes and 1, 2, 4, 8, 12, and 24 hours.

  8. Volume of Distribution (Vd) of KL0011034

    Calculated as Dose/(AUC0-∞ × λz), as applicable.

    Measured: Pre-induction and pre-maintenance; during infusion at 5, 10, 20, 30, and 45 minutes and 1, 2, or 3 hours as applicable; after infusion at 2, 5, 10, 20, 30, and 40 minutes and 1, 2, 4, 8, 12, and 24 hours.

  9. Terminal Elimination Rate Constant (λz) of KL0011034

    Estimated by log-linear regression of the terminal concentration-time phase using at least three points.

    Measured: Pre-induction and pre-maintenance; during infusion at 5, 10, 20, 30, and 45 minutes and 1, 2, or 3 hours as applicable; after infusion at 2, 5, 10, 20, 30, and 40 minutes and 1, 2, 4, 8, 12, and 24 hours.

  10. Terminal Elimination Half-Life (t1/2) of KL0011034

    Calculated as ln(2)/λz.

    Measured: Pre-induction and pre-maintenance; during infusion at 5, 10, 20, 30, and 45 minutes and 1, 2, or 3 hours as applicable; after infusion at 2, 5, 10, 20, 30, and 40 minutes and 1, 2, 4, 8, 12, and 24 hours.

  11. Mean Residence Time From Time Zero to Infinity (MRT0-∞) of KL0011034

    Calculated as AUMC/AUC0-∞.

    Measured: Pre-induction and pre-maintenance; during infusion at 5, 10, 20, 30, and 45 minutes and 1, 2, or 3 hours as applicable; after infusion at 2, 5, 10, 20, 30, and 40 minutes and 1, 2, 4, 8, 12, and 24 hours.

  12. Maximum Plasma Concentration (Cmax) of KL0011034 Metabolite A644S(A)-Z7

    Maximum observed plasma concentration.

    Measured: Pre-induction and pre-maintenance; during infusion at 5, 10, 20, 30, and 45 minutes and 1, 2, or 3 hours as applicable; after infusion at 2, 5, 10, 20, 30, and 40 minutes and 1, 2, 4, 8, 12, and 24 hours.

  13. Time to Maximum Plasma Concentration (Tmax) of KL0011034 Metabolite A644S(A)-Z7

    Time of the first occurrence of the maximum observed plasma concentration.

    Measured: Pre-induction and pre-maintenance; during infusion at 5, 10, 20, 30, and 45 minutes and 1, 2, or 3 hours as applicable; after infusion at 2, 5, 10, 20, 30, and 40 minutes and 1, 2, 4, 8, 12, and 24 hours.

  14. Area Under the Curve From Time Zero to the Last Quantifiable Concentration (AUC0-t) of KL0011034 Metabolite A644S(A)-Z7

    Calculated using the linear-up/log-down trapezoidal method.

    Measured: Pre-induction and pre-maintenance; during infusion at 5, 10, 20, 30, and 45 minutes and 1, 2, or 3 hours as applicable; after infusion at 2, 5, 10, 20, 30, and 40 minutes and 1, 2, 4, 8, 12, and 24 hours.

  15. Area Under the Curve From Time Zero Extrapolated to Infinity (AUC0-∞) of KL0011034 Metabolite A644S(A)-Z7

    Calculated as AUC0-t + Clast/λz.

    Measured: Pre-induction and pre-maintenance; during infusion at 5, 10, 20, 30, and 45 minutes and 1, 2, or 3 hours as applicable; after infusion at 2, 5, 10, 20, 30, and 40 minutes and 1, 2, 4, 8, 12, and 24 hours.

  16. Area Under the Curve From Time Zero to 24 Hours (AUC0-24h) of KL0011034 Metabolite A644S(A)-Z7

    Calculated using the linear-up/log-down trapezoidal method.

    Measured: Pre-induction and pre-maintenance; during infusion at 5, 10, 20, 30, and 45 minutes and 1, 2, or 3 hours as applicable; after infusion at 2, 5, 10, 20, 30, and 40 minutes and 1, 2, 4, 8, 12, and 24 hours.

  17. Percentage of AUC Extrapolated to Infinity (AUC%Extrap) of KL0011034 Metabolite A644S(A)-Z7

    Calculated as [(AUC0-∞ - AUC0-t)/AUC0-∞] × 100%.

    Measured: Pre-induction and pre-maintenance; during infusion at 5, 10, 20, 30, and 45 minutes and 1, 2, or 3 hours as applicable; after infusion at 2, 5, 10, 20, 30, and 40 minutes and 1, 2, 4, 8, 12, and 24 hours.

  18. Clearance (CL) of KL0011034 Metabolite A644S(A)-Z7

    Calculated as Dose/AUC0-∞, as applicable.

    Measured: Pre-induction and pre-maintenance; during infusion at 5, 10, 20, 30, and 45 minutes and 1, 2, or 3 hours as applicable; after infusion at 2, 5, 10, 20, 30, and 40 minutes and 1, 2, 4, 8, 12, and 24 hours.

  19. Volume of Distribution (Vd) of KL0011034 Metabolite A644S(A)-Z7

    Calculated as Dose/(AUC0-∞ × λz), as applicable.

    Measured: Pre-induction and pre-maintenance; during infusion at 5, 10, 20, 30, and 45 minutes and 1, 2, or 3 hours as applicable; after infusion at 2, 5, 10, 20, 30, and 40 minutes and 1, 2, 4, 8, 12, and 24 hours.

  20. Terminal Elimination Rate Constant (λz) of KL0011034 Metabolite A644S(A)-Z7

    Estimated by log-linear regression of the terminal concentration-time phase using at least three points.

    Measured: Pre-induction and pre-maintenance; during infusion at 5, 10, 20, 30, and 45 minutes and 1, 2, or 3 hours as applicable; after infusion at 2, 5, 10, 20, 30, and 40 minutes and 1, 2, 4, 8, 12, and 24 hours.

  21. Terminal Elimination Half-Life (t1/2) of KL0011034 Metabolite A644S(A)-Z7

    Calculated as ln(2)/λz.

    Measured: Pre-induction and pre-maintenance; during infusion at 5, 10, 20, 30, and 45 minutes and 1, 2, or 3 hours as applicable; after infusion at 2, 5, 10, 20, 30, and 40 minutes and 1, 2, 4, 8, 12, and 24 hours.

  22. Mean Residence Time From Time Zero to Infinity (MRT0-∞) of KL0011034 Metabolite A644S(A)-Z7

    Calculated as AUMC/AUC0-∞.

    Measured: Pre-induction and pre-maintenance; during infusion at 5, 10, 20, 30, and 45 minutes and 1, 2, or 3 hours as applicable; after infusion at 2, 5, 10, 20, 30, and 40 minutes and 1, 2, 4, 8, 12, and 24 hours.

  23. Maximum Plasma Concentration (Cmax) of Propofol

    Maximum observed plasma concentration.

    Measured: Pre-induction and pre-maintenance; during infusion at 5, 10, 20, 30, and 45 minutes and 1, 2, or 3 hours as applicable; after infusion at 2, 5, 10, 20, 30, and 40 minutes and 1, 2, 4, 8, 12, and 24 hours.

  24. Time to Maximum Plasma Concentration (Tmax) of Propofol

    Time of the first occurrence of the maximum observed plasma concentration.

    Measured: Pre-induction and pre-maintenance; during infusion at 5, 10, 20, 30, and 45 minutes and 1, 2, or 3 hours as applicable; after infusion at 2, 5, 10, 20, 30, and 40 minutes and 1, 2, 4, 8, 12, and 24 hours.

  25. Area Under the Curve From Time Zero to the Last Quantifiable Concentration (AUC0-t) of Propofol

    Calculated using the linear-up/log-down trapezoidal method.

    Measured: Pre-induction and pre-maintenance; during infusion at 5, 10, 20, 30, and 45 minutes and 1, 2, or 3 hours as applicable; after infusion at 2, 5, 10, 20, 30, and 40 minutes and 1, 2, 4, 8, 12, and 24 hours.

  26. Area Under the Curve From Time Zero Extrapolated to Infinity (AUC0-∞) of Propofol

    Calculated as AUC0-t + Clast/λz.

    Measured: Pre-induction and pre-maintenance; during infusion at 5, 10, 20, 30, and 45 minutes and 1, 2, or 3 hours as applicable; after infusion at 2, 5, 10, 20, 30, and 40 minutes and 1, 2, 4, 8, 12, and 24 hours.

  27. Area Under the Curve From Time Zero to 24 Hours (AUC0-24h) of Propofol

    Calculated using the linear-up/log-down trapezoidal method.

    Measured: Pre-induction and pre-maintenance; during infusion at 5, 10, 20, 30, and 45 minutes and 1, 2, or 3 hours as applicable; after infusion at 2, 5, 10, 20, 30, and 40 minutes and 1, 2, 4, 8, 12, and 24 hours.

  28. Percentage of AUC Extrapolated to Infinity (AUC%Extrap) of Propofol

    Calculated as [(AUC0-∞ - AUC0-t)/AUC0-∞] × 100%.

    Measured: Pre-induction and pre-maintenance; during infusion at 5, 10, 20, 30, and 45 minutes and 1, 2, or 3 hours as applicable; after infusion at 2, 5, 10, 20, 30, and 40 minutes and 1, 2, 4, 8, 12, and 24 hours.

  29. Clearance (CL) of Propofol

    Calculated as Dose/AUC0-∞, as applicable.

    Measured: Pre-induction and pre-maintenance; during infusion at 5, 10, 20, 30, and 45 minutes and 1, 2, or 3 hours as applicable; after infusion at 2, 5, 10, 20, 30, and 40 minutes and 1, 2, 4, 8, 12, and 24 hours.

  30. Volume of Distribution (Vd) of Propofol

    Calculated as Dose/(AUC0-∞ × λz), as applicable.

    Measured: Pre-induction and pre-maintenance; during infusion at 5, 10, 20, 30, and 45 minutes and 1, 2, or 3 hours as applicable; after infusion at 2, 5, 10, 20, 30, and 40 minutes and 1, 2, 4, 8, 12, and 24 hours.

  31. Terminal Elimination Rate Constant (λz) of Propofol

    Estimated by log-linear regression of the terminal concentration-time phase using at least three points.

    Measured: Pre-induction and pre-maintenance; during infusion at 5, 10, 20, 30, and 45 minutes and 1, 2, or 3 hours as applicable; after infusion at 2, 5, 10, 20, 30, and 40 minutes and 1, 2, 4, 8, 12, and 24 hours.

  32. Terminal Elimination Half-Life (t1/2) of Propofol

    Calculated as ln(2)/λz.

    Measured: Pre-induction and pre-maintenance; during infusion at 5, 10, 20, 30, and 45 minutes and 1, 2, or 3 hours as applicable; after infusion at 2, 5, 10, 20, 30, and 40 minutes and 1, 2, 4, 8, 12, and 24 hours.

  33. Mean Residence Time From Time Zero to Infinity (MRT0-∞) of Propofol

    Calculated as AUMC/AUC0-∞.

    Measured: Pre-induction and pre-maintenance; during infusion at 5, 10, 20, 30, and 45 minutes and 1, 2, or 3 hours as applicable; after infusion at 2, 5, 10, 20, 30, and 40 minutes and 1, 2, 4, 8, 12, and 24 hours.

  34. Sedation/Anesthesia Success Rate

    Proportion of participants meeting the protocol-defined success criterion: MOAA/S score ≤1 after anesthesia induction.

    Measured: Day 1, from start of anesthesia induction until MOAA/S ≤1, assessed up to 24 hours after the start of infusion.

  35. Duration With Bispectral Index ≤60

    Duration for which BIS is 60 or lower.

    Measured: Day 1, continuously from pre-induction until 10 minutes after full recovery.

  36. Total Duration With Bispectral Index 40 to 60

    Cumulative duration for which BIS remains between 40 and 60.

    Measured: Day 1, continuously from pre-induction until 10 minutes after full recovery.

  37. Time to MOAA/S Score ≤1

    Time from start of anesthesia induction to the first MOAA/S score ≤1.

    Measured: Day 1, from start of anesthesia induction until the first MOAA/S score ≤1, assessed every 20 seconds after induction up to 24 hours after the start of infusion.

  38. Total Duration With MOAA/S Score ≤1

    Cumulative duration during which MOAA/S score is ≤1.

    Measured: Day 1, from induction through recovery assessments, assessed up to 24 hours after the start of infusion.

  39. MOAA/S Sedation Score

    Sedation depth assessed using the Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scale. The scale ranges from 0 to 5, where 5 indicates responsive to normal tone of voice and 0 indicates no response to painful stimulus; higher scores indicate a more awake state.

    Measured: Day 1: pre-induction; every 20 seconds after induction until MOAA/S ≤1 (assessed up to 24 hours); at 5, 10, 15, 20, 30, 45 minutes and 1, 2, 3 hours after infusion start; and every 2 minutes after infusion end until 10 minutes after full recovery.

  40. Modified Aldrete Score

    Recovery assessed using the Modified Aldrete Score. The scale ranges from 0 to 10, where higher scores indicate better recovery; readiness to leave the recovery area requires three consecutive scores ≥9.

    Measured: Day 1, every 2 minutes after full recovery until three consecutive scores ≥9, assessed up to 24 hours after the start of infusion.

  41. Post-Anesthetic Discharge Scoring System Score

    Discharge readiness assessed using the Post-Anesthetic Discharge Scoring System (PADSS). The scale ranges from 0 to 10, where higher scores indicate better discharge readiness; readiness for discharge requires three consecutive scores ≥9.

    Measured: Day 1, every 5 minutes after three consecutive Aldrete scores ≥9 until three consecutive PADSS scores ≥9, assessed up to 24 hours after the start of infusion.

  42. Time to Full Recovery

    Time from end of continuous infusion to the first score of 5 in three consecutive MOAA/S scores of 5.

    Measured: Day 1, from end of infusion until full recovery, assessed up to 24 hours after the start of infusion.

  43. Time to Recovery-Area Discharge Readiness

    Time until three consecutive Modified Aldrete scores are ≥9.

    Measured: Day 1, from full recovery until recovery-area discharge criteria are met, assessed up to 24 hours after the start of infusion.

  44. Time to Hospital Discharge Readiness

    Time until three consecutive PADSS scores are ≥9.

    Measured: Day 1, from recovery-area discharge readiness until hospital discharge criteria are met, assessed up to 24 hours after the start of infusion.

  45. Mini-Mental State Examination Score

    Orientation and memory during recovery assessed using the Mini-Mental State Examination (MMSE). The scale ranges from 0 to 30, where higher scores indicate better cognitive function.

    Measured: Day -1, and within 30 minutes, 1 hour, 2 hours, and 4 hours after discharge readiness; later assessments may stop once the result is normal.

  46. Finger-to-Nose Test Result

    Motor coordination during recovery assessed using the finger-to-nose test.

    Measured: Day -1, and within 30 minutes, 1 hour, 2 hours, and 4 hours after discharge readiness; later assessments may stop once the result is normal.

  47. Anesthesiologist Satisfaction

    Anesthesiologist satisfaction with anesthesia, assessed using the protocol-specified satisfaction assessment.

    Measured: 30 minutes (±10 minutes) after full recovery on Day 1.

  48. Injection Site Reactions

    Incidence and severity of injection-site pain, tenderness, erythema, and induration/mass.

    Measured: Day 1: pre-dose; 10 seconds after induction; at infusion start; 1, 2, 3 hours after start; 10 minutes after full recovery; before Day 2 discharge; and at early termination (within 6 hours after infusion end).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2026
  2. Study start6 Nov 2026 (estimated)
  3. Primary completion5 Sep 2027 (estimated)
  4. Study completion5 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07841626
Sponsor's protocol ID
KL0011034-103
Status last verified
Sep 2026
First submitted
31 Aug 2026
Last updated
25 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data (IPD) will not be shared because this is a first-in-human or early-stage clinical trial involving a novel investigational drug. The data contain proprietary and confidential information that could compromise ongoing patent applications and future commercial development. Public data sharing at this stage may also violate our confidentiality agreements with the contract research organization (CRO) and regulatory authorities. Therefore, IPD sharing is not feasible until the drug receives market approval or the primary study results are fully published.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing KL0011034 Injection and Propofol Injectable Emulsion in people with Healthy Participants Study and General Anesthesia, run by The Third Xiangya Hospital of Central South University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jie Huang (+86 731 8991 8665, cellahuang1988@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Events and Serious Adverse Events (time frame: From informed consent through Day 2 discharge/early termination; unresolved adverse events are followed as specified in the protocol.). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07841626.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.

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