A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of KL0011034 Injection Administered by Continuous Infusion in Healthy Adult Subjects
17 de septiembre de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
30
Fase
- Fase 1
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Wei Qi
- Número de teléfono: 028-82339360
- Correo electrónico: qiw@kelun.com
Ubicaciones de estudio
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Hunan
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Changsha, Hunan, Porcelana, 410205
- The Third XIANGYA Hospital of Central South University
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Contacto:
- Guoping Yang
- Número de teléfono: 13974817168
- Correo electrónico: ygp9880@163.com
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Contacto:
- Saiying Wang
- Número de teléfono: 0731-88618150
- Correo electrónico: 1771303488@qq.com
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Sí
Descripción
Inclusion Criteria:
- Sign the informed consent form
- Health participants (Age: 18~45 years);
- Body Weight: Male≥50.0kg, Female≥45.0kg; 19 ≤BMI≤ 26.0kg/m2;
- There were no abnormalities in clinically significant physical examination, vital signs, 12-lead electrocardiogram, chest x-ray, abdominal B-ultrasound, laboratory tests;
- Agreed to use contraception for 3 months post-dose.
Exclusion Criteria:
- Allergy or Drug hypersensitivity;
- Clinically significant Medical History;
- History of anesthesia accident, history of serious adverse reactions of anesthesia, or family history of anesthesia accidents, or contraindications to general anesthesia;
- Dyspnoea or suspected difficult airway, or predicting difficult endotracheal intubation;
- History of bronchial asthma, chronic obstructive pulmonary disease, sleep apnea syndrome;
- History of adrenal insufficiency or adrenal tumor or hereditary heme biosynthesis disorder or hereditary acute porphyria;
- History of any surgery within 3 months;
- History of any Medication within 14 days;
- History of any clinical study within 3 months;
- History of any vaccine within 1 month;
- History of any drug abuse;
- Needle sickness, Hematosickness;
- Massive blood loss (> 400 mL) in the past 3 months;
- Female volunteers are pregnant or lactating;
- History of unprotected sex within 2 weeks;
- Heavy smoker ( more than 5 cigarettes/day) within 3 months;
- History of alcohol abuse,or heavy alcohol intake (more than 14 units a week) within 6 months;
- Heavy caffeine intake;
- History of grapefruit, xanthine-rich foods intake within 48 hours;
- Positive alcohol test;
- Positive nicotine test;
- Positive drugs of abuse test result.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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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).
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Intravenous injection, continuous infusion
Intravenous injection, continuous infusion
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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).
|
Intravenous injection, continuous infusion
Intravenous injection, continuous infusion
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|
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).
|
Intravenous injection, continuous infusion
Intravenous injection, continuous infusion
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Number of reported Adverse Events
Periodo de tiempo: 24 hours post-dose
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Safety and tolerability was assessed by the number of volunteers with adverse events.
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24 hours post-dose
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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PK parameter Cmax in plasma
Periodo de tiempo: 24 hours post-dose
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Maximum peak plasma concentration (Cmax) of KL0011034 and its metabolite
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24 hours post-dose
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PK parameter Tmax in plasma
Periodo de tiempo: 24 hours post-dose
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Time of Cmax (Tmax) of KL0011034 and its metabolite
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24 hours post-dose
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PK parameter AUC0-t in plasma
Periodo de tiempo: 24 hours post-dose
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Area under the concentration-time curve (AUC0-t) from time zero to time "t" of KL0011034 and its metabolite
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24 hours post-dose
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PK parameter AUC0-∞ in plasma
Periodo de tiempo: 24 hours post-dose
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AUC from time zero to infinity (AUC0-∞) of KL0011034 and its metabolite
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24 hours post-dose
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PK parameter t1/2 in plasma
Periodo de tiempo: 24 hours post-dose
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Terminal-phase elimination half-life (t1/2) of KL0011034 and its metabolite
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24 hours post-dose
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Modified Observer's Assessment of Alertness Sedation (MOAA/S) scale
Periodo de tiempo: Day 1
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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.
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Day 1
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Electroencephalogram bispectrality index (BIS) monitoring
Periodo de tiempo: Day 1
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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.
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Day 1
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Modified Aldrete Scoring (Aldrete) Scale
Periodo de tiempo: Day 1
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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.
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Day 1
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Post-Anesthetic Discharge Scoring System
Periodo de tiempo: Day 1
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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.
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Day 1
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The time of complete awakening
Periodo de tiempo: Day 1
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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.
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Day 1
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Mini-Mental State Examination
Periodo de tiempo: Day 1
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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.
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Day 1
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Anesthesia satisfaction
Periodo de tiempo: Day 1
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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
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
13 de octubre de 2026
Finalización primaria (Estimado)
13 de noviembre de 2026
Finalización del estudio (Estimado)
13 de noviembre de 2026
Fechas de registro del estudio
Enviado por primera vez
11 de septiembre de 2026
Primero enviado que cumplió con los criterios de control de calidad
17 de septiembre de 2026
Publicado por primera vez (Actual)
18 de septiembre de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
18 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
17 de septiembre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- KL0011034-103
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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