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A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of KL0011034 Injection Administered by Continuous Infusion in Healthy Adult Subjects

17. september 2026 opdateret af: Hunan Kelun Pharmaceutical Co., Ltd.

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

30

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Kina
    • Hunan
      • Changsha, Hunan, Kina, 410205
        • The Third XIANGYA Hospital of Central South University
        • Kontakt:
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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).
Medicin: KL0011034 injection
Intravenous injection, continuous infusion
Medicin: propofol injectable emulsion
Intravenous injection, continuous infusion
Eksperimentel: 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).
Medicin: KL0011034 injection
Intravenous injection, continuous infusion
Medicin: propofol injectable emulsion
Intravenous injection, continuous infusion
Eksperimentel: 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).
Medicin: KL0011034 injection
Intravenous injection, continuous infusion
Medicin: propofol injectable emulsion
Intravenous injection, continuous infusion

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of reported Adverse Events
Tidsramme: 24 hours post-dose
Safety and tolerability was assessed by the number of volunteers with adverse events.
24 hours post-dose

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
PK parameter Cmax in plasma
Tidsramme: 24 hours post-dose
Maximum peak plasma concentration (Cmax) of KL0011034 and its metabolite
24 hours post-dose
PK parameter Tmax in plasma
Tidsramme: 24 hours post-dose
Time of Cmax (Tmax) of KL0011034 and its metabolite
24 hours post-dose
PK parameter AUC0-t in plasma
Tidsramme: 24 hours post-dose
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
Tidsramme: 24 hours post-dose
AUC from time zero to infinity (AUC0-∞) of KL0011034 and its metabolite
24 hours post-dose
PK parameter t1/2 in plasma
Tidsramme: 24 hours post-dose
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
Tidsramme: 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.
Day 1
Electroencephalogram bispectrality index (BIS) monitoring
Tidsramme: 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.
Day 1
Modified Aldrete Scoring (Aldrete) Scale
Tidsramme: 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.
Day 1
Post-Anesthetic Discharge Scoring System
Tidsramme: 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.
Day 1
The time of complete awakening
Tidsramme: 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.
Day 1
Mini-Mental State Examination
Tidsramme: 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.
Day 1
Anesthesia satisfaction
Tidsramme: 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.
Day 1

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Hunan Kelun Pharmaceutical Co., Ltd.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

13. oktober 2026

Primær færdiggørelse (Anslået)

13. november 2026

Studieafslutning (Anslået)

13. november 2026

Datoer for studieregistrering

Først indsendt

11. september 2026

Først indsendt, der opfyldte QC-kriterier

17. september 2026

Først opslået (Faktiske)

18. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • KL0011034-103

Plan for individuelle deltagerdata (IPD)

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