A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of KL0011034 Injection Administered by Continuous Infusion in Healthy Adult Subjects
17 september 2026 uppdaterad av: 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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
30
Fas
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Wei Qi
- Telefonnummer: 028-82339360
- E-post: qiw@kelun.com
Studieorter
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Hunan
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Changsha, Hunan, Kina, 410205
- The Third XIANGYA Hospital of Central South University
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Kontakt:
- Guoping Yang
- Telefonnummer: 13974817168
- E-post: ygp9880@163.com
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Kontakt:
- Saiying Wang
- Telefonnummer: 0731-88618150
- E-post: 1771303488@qq.com
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Ja
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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).
|
Intravenous injection, continuous infusion
Intravenous injection, continuous infusion
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Experimentell: 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
|
|
Experimentell: 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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Number of reported Adverse Events
Tidsram: 24 hours post-dose
|
Safety and tolerability was assessed by the number of volunteers with adverse events.
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24 hours post-dose
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
PK parameter Cmax in plasma
Tidsram: 24 hours post-dose
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Maximum peak plasma concentration (Cmax) of KL0011034 and its metabolite
|
24 hours post-dose
|
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PK parameter Tmax in plasma
Tidsram: 24 hours post-dose
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Time of Cmax (Tmax) of KL0011034 and its metabolite
|
24 hours post-dose
|
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PK parameter AUC0-t in plasma
Tidsram: 24 hours post-dose
|
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
Tidsram: 24 hours post-dose
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AUC from time zero to infinity (AUC0-∞) of KL0011034 and its metabolite
|
24 hours post-dose
|
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PK parameter t1/2 in plasma
Tidsram: 24 hours post-dose
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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
Tidsram: 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
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Electroencephalogram bispectrality index (BIS) monitoring
Tidsram: 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.
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Day 1
|
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Modified Aldrete Scoring (Aldrete) Scale
Tidsram: 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.
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Day 1
|
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Post-Anesthetic Discharge Scoring System
Tidsram: 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.
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Day 1
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The time of complete awakening
Tidsram: 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
Tidsram: 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
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Anesthesia satisfaction
Tidsram: 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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Samarbetspartners och utredare
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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
13 oktober 2026
Primärt slutförande (Beräknad)
13 november 2026
Avslutad studie (Beräknad)
13 november 2026
Studieregistreringsdatum
Först inskickad
11 september 2026
Först inskickad som uppfyllde QC-kriterierna
17 september 2026
Första postat (Faktisk)
18 september 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
18 september 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
17 september 2026
Senast verifierad
1 september 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- KL0011034-103
Plan för individuella deltagardata (IPD)
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