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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 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

30

Phase

  • Phase 1

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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).
Arzneimittel: KL0011034 injection
Intravenous injection, continuous infusion
Arzneimittel: 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).
Arzneimittel: KL0011034 injection
Intravenous injection, continuous infusion
Arzneimittel: 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).
Arzneimittel: KL0011034 injection
Intravenous injection, continuous infusion
Arzneimittel: propofol injectable emulsion
Intravenous injection, continuous infusion

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of reported Adverse Events
Zeitfenster: 24 hours post-dose
Safety and tolerability was assessed by the number of volunteers with adverse events.
24 hours post-dose

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
PK parameter Cmax in plasma
Zeitfenster: 24 hours post-dose
Maximum peak plasma concentration (Cmax) of KL0011034 and its metabolite
24 hours post-dose
PK parameter Tmax in plasma
Zeitfenster: 24 hours post-dose
Time of Cmax (Tmax) of KL0011034 and its metabolite
24 hours post-dose
PK parameter AUC0-t in plasma
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Hunan Kelun Pharmaceutical Co., Ltd.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

13. Oktober 2026

Primärer Abschluss (Geschätzt)

13. November 2026

Studienabschluss (Geschätzt)

13. November 2026

Studienanmeldedaten

Zuerst eingereicht

11. September 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

17. September 2026

Zuerst gepostet (Tatsächlich)

18. September 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

18. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

17. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • KL0011034-103

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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