临床试验/NCT07751094

NCT07751094尚未招募1 期

A Single-Center, Randomized, Open-Label, Three-Sequence, Three-Period Crossover Study to Evaluate the Drug-Drug Interaction Between KL0011034 Injection and Alfentanil Hydrochloride Injection in Trial Participants With Moderate-to-Severe Non-Cancer Chronic Pain

The Third Xiangya Hospital of Central South University0 个研究点目标入组 27 人开始时间: 2026年7月30日最近更新: 2026年8月7日

适应症

干预措施

试验速览

阶段: 1 期
状态: 尚未招募
发起方: The Third Xiangya Hospital of Central South University
入组人数: 27
主要终点: Maximum Plasma Concentration (Cmax) of KL0011034

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

This study will evaluate the drug-drug interaction between KL0011034 Injection and Alfentanil Hydrochloride Injection in participants with moderate-to-severe non-cancer chronic pain. The study consists of two parts. Part 1 is a single-center, randomized, open-label, parallel-design study to evaluate the safety, tolerability, and pharmacodynamics of the combination. Approximately 9 participants will be enrolled and randomized to one of three dose groups (n=3 per group). Part 2 is a single-center, randomized, open-label, three-sequence, three-period crossover study to evaluate the pharmacokinetic interaction, safety, tolerability, and pharmacodynamic effects. Approximately 18 participants will be enrolled and randomized to one of three sequences (n=6 per sequence), with a 3-day washout period between each period.

详细描述

Study Design and Population:

This is a two-part, single-center, randomized, open-label study in participants with moderate-to-severe non-cancer chronic pain. Part 1 uses a parallel-group design, and Part 2 uses a three-sequence, three-period crossover design.

Part 1 (Safety, Tolerability, and Pharmacodynamics):

Approximately 9 participants will be randomized in a 1:1:1 ratio to one of three dose groups to receive a single combined dose of Alfentanil Hydrochloride Injection 5 μg/kg plus KL0011034 Injection at one of three dose levels (Group 1: 0.3 mg/kg; Group 2: 0.35 mg/kg; Group 3: 0.4 mg/kg). Pharmacodynamic and safety evaluations will be conducted, and participants will be discharged after the end-of-study examinations on Day 2 (D2). Based on the results from Part 1, the maximum dose of KL0011034 Injection among the three dose levels that is deemed safe and tolerable will be selected for use in Part 2.

Part 2 (Pharmacokinetic Interaction, Safety, Tolerability, and Pharmacodynamics):

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 55 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•Those who fully understand the purpose, content, process and possible risks of the trial, and voluntarily participate and sign the informed consent form;
•Male and female patients with moderate to severe non-cancerous chronic pain (such as patients with shoulder inflammation, chronic back pain, myofascial pain syndrome) aged between 18 and 55 years (inclusive of the boundary values), with a NRS score of >= 4;
•Male weight not less than 50.0 kg, female weight not less than 45.0 kg; Body Mass Index (BMI) within the range of 19.0 to 26.0 kg/m2 (including the critical value);
•From the date of signing the informed consent form to the last administration of the trial medication within 3 months, the trial participants (and their partners) have no plans for conception, and the trial participants have no plans for sperm donation/egg donation; From the date of signing the informed consent form to the completion of the exit examination, the participants voluntarily adopt non-pharmacological contraceptive measures; After the exit examination to the last 3 months after the last administration of the trial medication, the participants voluntarily adopt effective contraceptive measures;
•Able to communicate well with the researchers, willing and able to comply with the lifestyle restrictions stipulated in the protocol, and cooperate to complete the trial process.

排除标准

•Known to be allergic to alfentanil or other opioid analgesics, etomidate or other anesthetic drugs, or to be of allergic constitution (such as allergy to two or more drugs, food or pollen), or prone to develop rashes, urticaria, etc., or having a history of allergic diseases, or known to be allergic to the excipients or raw materials of this product;
•Having a history of head trauma, possible intracranial hypertension, cerebral aneurysm, cerebrovascular accident, or mental illness such as schizophrenia, mania, bipolar disorder, mental confusion, long-term use of psychotropic drugs or cognitive dysfunction;
•Having a history of serious cardiovascular diseases (such as hypertension, heart failure, severe arrhythmia, etc.) and/or heart diseases, family history of heart disease and/or unstable angina pectoris, or having had a myocardial infarction in the past 6 months;
•Having a history of other cardiovascular, endocrine, respiratory, digestive, urinary, nervous, hematological and/or lymphatic system diseases, and the investigator considers that it still has clinical significance during the screening;
•Having a history of anesthesia accidents, severe adverse reactions during anesthesia or family history of anesthesia accidents, or having contraindications for general anesthesia;
•Having difficulty breathing or suspected difficult airway or estimated difficulty in tracheal intubation (such as modified Mallampati score grade III-IV, congenital small tongue, maldevelopment of mandible, etc.);
•Having a history of airway diseases such as bronchial asthma, chronic obstructive pulmonary disease, sleep apnea syndrome, etc.;
•Having a history of adrenal insufficiency, adrenal tumor or hereditary hemoglobin biosynthesis disorder or hereditary acute porphyria;
•Having a surgical history within 3 months before screening, or not recovering from surgery, or having planned surgery during the trial;
•Having conditions, surgical history, diseases related to the use of the test drug, or any other special circumstances that may significantly affect drug absorption, distribution, metabolism and excretion;
•Abnormal results of physical examination, vital signs, full thoracic radiograph, abdominal B-ultrasound, laboratory tests (blood routine, urine routine, blood biochemistry, coagulation function) have clinical significance;
•Having clinically significant electrocardiogram abnormalities found during screening, such as QTcF >=450 ms (male) or >=460 ms (female), etc.;
•Positive for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab), and syphilis spirochete antibody (TP-Ab);
•Having unprotected sexual behavior within 2 weeks before the first administration of the test drug;
•Female subjects during the screening period are in pregnancy or lactation, or have a positive pregnancy result;
•Having a history of drug abuse or drug dependence within the past 1 year, or having a positive urine drug screening at the time of screening;
•Having a history of alcohol abuse within 6 months before screening [that is, consuming more than 14 standard units of alcohol per week (1 unit = 360 ml of beer or 45 ml of 40% alcohol liquor or 150 ml of wine)], or being unwilling to stop drinking alcohol or any alcoholic products during the trial, or having a positive alcohol breath test at the time of screening;
•Having a history of smoking within 3 months before screening (daily smoking quantity >= 5 cigarettes), or being unwilling to stop using any tobacco products during the trial, or having a positive smoke test result at the time of screening;
•Having consumed excessive (8 cups or more, 1 cup = 250 ml) tea, coffee or caffeine-containing beverages (such as milk tea, cola, etc.) every day within 14 days before screening, or being unwilling to stop drinking these beverages during the trial;
•Individuals who consumed grapefruit/grapefruit juice, foods or beverages rich in xanthine components (such as shiitake mushrooms, white carp, black carp, whelk, white bream, oysters, white snapper, sea eel, duck liver, chicken liver, pork intestines, pork liver, beef liver, etc.) within 48 hours before the first administration of the test drug, or those who had any special diet that could affect the absorption, distribution, metabolism, or excretion of the drug;
•Individuals who had used any medication within 14 days before the first administration of the test drug, including prescription drugs, over-the-counter drugs, traditional Chinese medicines, health supplements, and vitamins;
•Individuals who had used inhibitors or inducers of CYP3A4 or CYP2C19 (such as CYP3A4 inhibitors: sirivatinib, atalenti, edalizumab, telifast, clarithromycin, itraconazole, ketoconazole, posaconazole, voriconazole, indinavir, nelfinavir, ritonavir, sapparin, tipranavir, lopinavir, nafamoxin, cobizumet; CYP3A4 inducers: apalutamide, enzalutamide, rumactat, mitotane, evolizumab, phenytoin, carbamazepine, rifampicin, St. John's wort; CYP2C19 inhibitors: fluvoxamine, fluconazole, fluoxetine, ticlopidine, phenabarbital, nalfurafine, voriconazole; CYP2C19 inducers: rifampicin, apalutamide, efavirenz, enzalutamide, phenytoin) within 1 month before the first administration of the test drug;
•Individuals who had been using sedative drugs and/or opioid analgesics for more than 3 months before screening;
•Individuals who had participated in any clinical trials and used the test drug/medical device within 3 months before the first administration of the test drug, or were still in the follow-up period of other trials;
•Individuals who had received inactivated vaccines within 1 month before screening, or received live/deleted vaccines within 3 months before screening, or planned to receive inactivated/live/deleted vaccines during the trial;
•Individuals who had undergone blood loss or blood donation or transfusion or received a total amount of blood products exceeding 400 ml within 3 months before screening, or planned to donate blood or undergo surgery within 1 month after the trial or after the trial ends;
•Individuals with difficulty in blood collection, or those who cannot tolerate venipuncture, or those with a history of fainting or needle shock;
•Individuals with poor compliance, or other situations that the researcher deems unsuitable for participation in the study.

研究组 & 干预措施

1.Alfentanil 5 µg/kg + KL0011034 0.3 mg/kg

Experimental

Part 1: Participants receive a single dose of Alfentanil Hydrochloride Injection 5 μg/kg combined with KL0011034 Injection 0.3 mg/kg on Day 1. Safety, tolerability, and pharmacodynamic evaluations are conducted.

干预措施: KL0011034 injection (Drug)

1.Alfentanil 5 µg/kg + KL0011034 0.3 mg/kg

Experimental

干预措施: Alfentanil Hydrochloride Injection (Drug)

2.Alfentanil 5 µg/kg + KL0011034 0.35 mg/kg

Experimental

Part 1: Participants receive a single dose of Alfentanil Hydrochloride Injection 5 μg/kg combined with KL0011034 Injection 0.35 mg/kg on Day 1. Safety, tolerability, and pharmacodynamic evaluations are conducted.

干预措施: KL0011034 injection (Drug)

2.Alfentanil 5 µg/kg + KL0011034 0.35 mg/kg

Experimental

干预措施: Alfentanil Hydrochloride Injection (Drug)

3.Alfentanil 5 µg/kg + KL0011034 0.4 mg/kg

Experimental

Part 1: Participants receive a single dose of Alfentanil Hydrochloride Injection 5 μg/kg combined with KL0011034 Injection 0.4 mg/kg on Day 1. Safety, tolerability, and pharmacodynamic evaluations are conducted.

干预措施: KL0011034 injection (Drug)

3.Alfentanil 5 µg/kg + KL0011034 0.4 mg/kg

Experimental

干预措施: Alfentanil Hydrochloride Injection (Drug)

4.Sequence A: KL0011034 → Alfentanil → Alfentanil + KL0011034

Experimental

Part 2, Sequence A: Participants receive three interventions across three periods (Day 1, Day 4, Day 7) with a 3-day washout between periods: Period 1: KL0011034 Injection (selected dose from Part 1); Period 2: Alfentanil Hydrochloride Injection 5 μg/kg; Period 3: Alfentanil Hydrochloride Injection 5 μg/kg + KL0011034 Injection (selected dose from Part 1). Pharmacokinetic, pharmacodynamic, and safety evaluations are conducted.

干预措施: KL0011034 injection (Drug)

4.Sequence A: KL0011034 → Alfentanil → Alfentanil + KL0011034

Experimental

干预措施: Alfentanil Hydrochloride Injection (Drug)

5. Sequence B: Alfentanil → Alfentanil + KL0011034 → KL0011034

Experimental

Part 2, Sequence B: Participants receive three interventions across three periods (Day 1, Day 4, Day 7) with a 3-day washout between periods: Period 1: Alfentanil Hydrochloride Injection 5 μg/kg; Period 2: Alfentanil Hydrochloride Injection 5 μg/kg + KL0011034 Injection (selected dose from Part 1); Period 3: KL0011034 Injection (selected dose from Part 1). Pharmacokinetic, pharmacodynamic, and safety evaluations are conducted.

干预措施: KL0011034 injection (Drug)

5. Sequence B: Alfentanil → Alfentanil + KL0011034 → KL0011034

Experimental

干预措施: Alfentanil Hydrochloride Injection (Drug)

6. Sequence C: Alfentanil + KL0011034 → KL0011034 → Alfentanil

Experimental

Part 2, Sequence C: Participants receive three interventions across three periods (Day 1, Day 4, Day 7) with a 3-day washout between periods: Period 1: Alfentanil Hydrochloride Injection 5 μg/kg + KL0011034 Injection (selected dose from Part 1); Period 2: KL0011034 Injection (selected dose from Part 1); Period 3: Alfentanil Hydrochloride Injection 5 μg/kg. Pharmacokinetic, pharmacodynamic, and safety evaluations are conducted.

干预措施: KL0011034 injection (Drug)

6. Sequence C: Alfentanil + KL0011034 → KL0011034 → Alfentanil

Experimental

干预措施: Alfentanil Hydrochloride Injection (Drug)

结局指标

主要结局

Maximum Plasma Concentration (Cmax) of KL0011034

时间窗: Part 2, each of the 3 treatment periods (Day 1, Day 4, Day 7): pre-dose (within 60 minutes before dosing); immediately after infusion completion, and at 2, 5, 10, 15, 20, 30, 40, 50 minutes, and 1, 2, 4, 8, 12, 24 hours

Cmax of KL0011034 in plasma, determined by non-compartmental analysis of concentration-time data.

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

Cmax of KL0011034 major metabolite A644S(A)-Z7 in plasma, determined by non-compartmental analysis of concentration-time data.

Maximum Plasma Concentration (Cmax) of Alfentanil

时间窗: Part 2, each of the 3 treatment periods (Day 1, Day 4, Day 7): pre-dose (within 60 minutes before dosing); immediately after bolus completion, and at 1, 2, 3, 6, 11, 16, 21, 31, 41, 51, 61 minutes, and 2, 4, 8, 12, 24 hours post-dose.

Cmax of Alfentanil in plasma, determined by non-compartmental analysis of concentration-time data.

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

AUC0-t of KL0011034 in plasma, determined by non-compartmental analysis using linear-log trapezoidal method.

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

AUC0-t of KL0011034 major metabolite A644S(A)-Z7 in plasma, determined by non-compartmental analysis using linear-log trapezoidal method.

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

AUC0-t of Alfentanil in plasma, determined by non-compartmental analysis using linear-log trapezoidal method.

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

AUC0-∞ of KL0011034 in plasma, calculated as AUC0-t + Clast/λz.

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

AUC0-∞ of KL0011034 major metabolite A644S(A)-Z7 in plasma, calculated as AUC0-t + Clast/λz.

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

时间窗: Part 2, each of the 3 treatment periods (Day 1, Day 4, Day 7): pre-dose (within 60 minutes before dosing);immediately after infusion completion, and at 2, 5, 10, 15, 20, 30, 40, 50 minutes, and 1, 2, 4, 8, 12, 24 hours

AUC0-∞ of Alfentanil in plasma, calculated as AUC0-t + Clast/λz.

次要结局

Mean Residence Time (MRT0-∞) of Alfentanil(Part 2, each of the 3 treatment periods (Day 1, Day 4, Day 7): pre-dose (within 60 minutes before dosing); immediately after bolus completion, and at 1, 2, 3, 6, 11, 16, 21, 31, 41, 51, 61 minutes, and 2, 4, 8, 12, 24 hours post-dose.)
Area Under the Curve From Time Zero to 24 Hours (AUC0-24h) of KL0011034 Metabolite A644S(A)-Z7(Part 2, each of the 3 treatment periods (Day 1, Day 4, Day 7): pre-dose (within 60 minutes before dosing); immediately after infusion completion, and at 2, 5, 10, 15, 20, 30, 40, 50 minutes, and 1, 2, 4, 8, 12, 24 hours post-dose.)
Area Under the Curve From Time Zero to 24 Hours (AUC0-24h) of Alfentanil(Part 2, each of the 3 treatment periods (Day 1, Day 4, Day 7): pre-dose (within 60 minutes before dosing); immediately after bolus completion, and at 1, 2, 3, 6, 11, 16, 21, 31, 41, 51, 61 minutes, and 2, 4, 8, 12, 24 hours post-dose.)
Elimination Half-Life (t1/2) of KL0011034(Part 2, each of the 3 treatment periods (Day 1, Day 4, Day 7): pre-dose (within 60 minutes before dosing); immediately after infusion completion, and at 2, 5, 10, 15, 20, 30, 40, 50 minutes, and 1, 2, 4, 8, 12, 24 hours post-dose.)
Adverse Events and Serious Adverse Events(From signing of informed consent through study completion (up to Day 8 in Part 2); unresolved AEs followed every 2 weeks until resolution or stabilization, up to 28 days after last dose.)
Vital Signs(Part 2: Screening, Day -1, pre-dose on Day 3 and Day 6, pre-dose and at 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, and 24 hours post-dose in each treatment period (Day 1, Day 4, Day 7), and on Day 8 (end-of-study).)
12-Lead Electrocardiogram Parameters(Part 2: Screening, Day -1, pre-dose on Day 3 and Day 6, pre-dose and at 30 minutes, 2 hours, 4 hours, 8 hours, 12 hours, and 24 hours post-dose in each treatment period (Day 1, Day 4, Day 7), and on Day 8 (end-of-study).)
Physical Examination(Part 2: Screening, Day -1, and Day 8 (end-of-study).)
Elimination Half-Life (t1/2) of KL0011034 Metabolite A644S(A)-Z7(Part 2, each of the 3 treatment periods (Day 1, Day 4, Day 7): pre-dose (within 60 minutes before dosing); immediately after infusion completion, and at 2, 5, 10, 15, 20, 30, 40, 50 minutes, and 1, 2, 4, 8, 12, 24 hours post-dose.)
Elimination Half-Life (t1/2) of Alfentanil(Part 2, each of the 3 treatment periods (Day 1, Day 4, Day 7): pre-dose (within 60 minutes before dosing); immediately after bolus completion, and at 1, 2, 3, 6, 11, 16, 21, 31, 41, 51, 61 minutes, and 2, 4, 8, 12, 24 hours post-dose.)
Apparent Volume of Distribution (Vd) of KL0011034(Part 2, each of the 3 treatment periods (Day 1, Day 4, Day 7): pre-dose (within 60 minutes before dosing); immediately after infusion completion, and at 2, 5, 10, 15, 20, 30, 40, 50 minutes, and 1, 2, 4, 8, 12, 24 hours post-dose.)
Apparent Volume of Distribution (Vd) of KL0011034 Metabolite A644S(A)-Z7(Part 2, each of the 3 treatment periods (Day 1, Day 4, Day 7): pre-dose (within 60 minutes before dosing); immediately after infusion completion, and at 2, 5, 10, 15, 20, 30, 40, 50 minutes, and 1, 2, 4, 8, 12, 24 hours post-dose.)
Apparent Volume of Distribution (Vd) of Alfentanil(Part 2, each of the 3 treatment periods (Day 1, Day 4, Day 7): pre-dose (within 60 minutes before dosing); immediately after bolus completion, and at 1, 2, 3, 6, 11, 16, 21, 31, 41, 51, 61 minutes, and 2, 4, 8, 12, 24 hours post-dose.)
Clearance (CL) of KL0011034(Part 2, each of the 3 treatment periods (Day 1, Day 4, Day 7): pre-dose (within 60 minutes before dosing); immediately after infusion completion, and at 2, 5, 10, 15, 20, 30, 40, 50 minutes, and 1, 2, 4, 8, 12, 24 hours post-dose.)
Clearance (CL) of KL0011034 Metabolite A644S(A)-Z7(Part 2, each of the 3 treatment periods (Day 1, Day 4, Day 7): pre-dose (within 60 minutes before dosing); immediately after infusion completion, and at 2, 5, 10, 15, 20, 30, 40, 50 minutes, and 1, 2, 4, 8, 12, 24 hours post-dose.)
Clearance (CL) of Alfentanil(Part 2, each of the 3 treatment periods (Day 1, Day 4, Day 7): pre-dose (within 60 minutes before dosing); immediately after bolus completion, and at 1, 2, 3, 6, 11, 16, 21, 31, 41, 51, 61 minutes, and 2, 4, 8, 12, 24 hours post-dose.)
Terminal Elimination Rate Constant (λz) of KL0011034(Part 2, each of the 3 treatment periods (Day 1, Day 4, Day 7): pre-dose (within 60 minutes before dosing); immediately after infusion completion, and at 2, 5, 10, 15, 20, 30, 40, 50 minutes, and 1, 2, 4, 8, 12, 24 hours post-dose.)
Terminal Elimination Rate Constant (λz) of KL0011034 Metabolite A644S(A)-Z7(Part 2, each of the 3 treatment periods (Day 1, Day 4, Day 7): pre-dose (within 60 minutes before dosing); immediately after infusion completion, and at 2, 5, 10, 15, 20, 30, 40, 50 minutes, and 1, 2, 4, 8, 12, 24 hours post-dose.)
Terminal Elimination Rate Constant (λz) of Alfentanil(Part 2, each of the 3 treatment periods (Day 1, Day 4, Day 7): pre-dose (within 60 minutes before dosing); immediately after bolus completion, and at 1, 2, 3, 6, 11, 16, 21, 31, 41, 51, 61 minutes, and 2, 4, 8, 12, 24 hours post-dose.)
Time to Maximum Plasma Concentration (Tmax) of KL0011034(Part 2, each of the 3 treatment periods (Day 1, Day 4, Day 7): pre-dose (within 60 minutes before dosing); immediately after infusion completion, and at 2, 5, 10, 15, 20, 30, 40, 50 minutes, and 1, 2, 4, 8, 12, 24 hours post-dose.)
Mean Residence Time (MRT0-∞) of KL0011034(Part 2, each of the 3 treatment periods (Day 1, Day 4, Day 7): pre-dose (within 60 minutes before dosing); immediately after infusion completion, and at 2, 5, 10, 15, 20, 30, 40, 50 minutes, and 1, 2, 4, 8, 12, 24 hours post-dose.)
Mean Residence Time (MRT0-∞) of KL0011034 Metabolite A644S(A)-Z7(Part 2, each of the 3 treatment periods (Day 1, Day 4, Day 7): pre-dose (within 60 minutes before dosing); immediately after infusion completion, and at 2, 5, 10, 15, 20, 30, 40, 50 minutes, and 1, 2, 4, 8, 12, 24 hours post-dose.)
Time to Maximum Plasma Concentration (Tmax) of KL0011034 Metabolite A644S(A)-Z7(Part 2, each of the 3 treatment periods (Day 1, Day 4, Day 7): pre-dose (within 60 minutes before dosing); immediately after infusion completion, and at 2, 5, 10, 15, 20, 30, 40, 50 minutes, and 1, 2, 4, 8, 12, 24 hours post-dose.)
Time to Maximum Plasma Concentration (Tmax) of Alfentanil(Part 2, each of the 3 treatment periods (Day 1, Day 4, Day 7): pre-dose (within 60 minutes before dosing); immediately after bolus completion, and at 1, 2, 3, 6, 11, 16, 21, 31, 41, 51, 61 minutes, and 2, 4, 8, 12, 24 hours post-dose.)
Area Under the Curve From Time Zero to 24 Hours (AUC0-24h) of KL0011034(Part 2, each of the 3 treatment periods (Day 1, Day 4, Day 7): pre-dose (within 60 minutes before dosing); immediately after infusion completion, and at 2, 5, 10, 15, 20, 30, 40, 50 minutes, and 1, 2, 4, 8, 12, 24 hours post-dose.)
Eyelash Reflex(Part 1 and Part 2: From pre-dose (-5 minutes) every 15 seconds until eyelash reflex recovery, with minimum assessment up to 2 minutes post-dose; for participants with no loss of reflex within 5 minutes post-dose, evaluated every 15 seconds up to 5 minute)
Modified Aldrete Score for Discharge Readiness(Part 1 and Part 2: From awakening, every 2 minutes until discharge criteria met (score ≥9 on 3 consecutive assessments); for participants with no response, starting at 10 minutes post-dose, every 2 minutes until discharge criteria met.)
Injection Site Reactions(Part 2: Pre-dose, immediately post-dose plus 30 seconds, and at 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, and 6 hours post-dose in each treatment period (Day 1, Day 4, and Day 7).)
MOAA/S Sedation Score(Part 1 and Part 2: From pre-dose (-5 minutes) at 20 seconds, 40 seconds, 1 minute, 1 minute 20 seconds, 1 minute 40 seconds, 2 minutes, 2 minutes 20 seconds, 2 minutes 40 seconds, 3 minutes, and every minute thereafter until full recovery plus 10 minutes)
Bispectral Index (BIS) Monitoring(Part 1 and Part 2: From pre-dose (-5 minutes) continuously until full recovery plus 10 minutes (recorded every 1 minute); up to 10 minutes post-dose for participants with no response.)

研究者

发起方

The Third Xiangya Hospital of Central South University

申办方类型

Other

责任方

Principal Investigator

主要研究者

Guoping Yang

Professor of Clinical Pharmacology

The Third Xiangya Hospital of Central South University

相似试验

已完成

1 期

A Study Evaluating the Drug-Drug Interaction Between KL0011034 Injection and Alfentanil Hydrochloride InjectionChronic Pain

NCT07710560Hunan Kelun Pharmaceutical Co., Ltd.27

进行中（未招募）

1 期

评价 KL0011034 注射液与盐酸阿芬太尼注射液药物相互作用的研究非气管插管的手术 / 操作(如胃镜、肠镜、胃肠镜)中的镇静和麻醉

CTR20262595湖南科伦制药有限公司 / 四川科伦药物研究院有限公司

招募中

1 期

A Study Evaluating the Effects of Itraconazole or Rifampin on the Pharmacokinetic Characteristics of Rocbrutinib Tablet

NCT07374224Guangzhou Lupeng Pharmaceutical Company LTD.28

招募中

1 期

评价 KL0011034 注射液在健康受试者中的安全性、耐受性和药代动力学研究非气管插管的手术 / 操作(如胃镜、肠镜、胃肠镜)中的镇静和麻醉

CTR20260622湖南科伦制药有限公司 / 四川科伦药物研究院有限公司

进行中（未招募）

1 期

评价 KL0011034 注射液在健康受试者中的安全性、耐受性和药代动力学研究非气管插管的手术 / 操作(如胃镜、肠镜、胃肠镜)中的镇静和麻醉

CTR20260622湖南科伦制药有限公司 / 四川科伦药物研究院有限公司