Chronic PainPhase 1NCT07751094

A Study to Evaluate the Drug-Drug Interaction Between KL0011034 Injection and Alfentanil Hydrochloride Injection in Participants With Moderate-to-Severe Non-Cancer Chronic Pain

A Phase 1 study testing KL0011034 injection and Alfentanil Hydrochloride Injection in people with Chronic Pain, run by The Third Xiangya Hospital of Central South University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Chronic Pain
What is being tested?: KL0011034 injection and Alfentanil Hydrochloride Injection
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 27 participants
Where: No sites listed yet
Study dates: 30 Jul 2026to 31 Jul 2027
Phase: Phase 1
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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.);

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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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Huang Jie contact

+86 731 8991 8665

cellahuang1988@163.com

About this study

Official title: 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

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.

Read the detailed description

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):

Approximately 18 participants will be randomized in a 1:1:1 ratio to one of three sequences (A, B, or C), with 6 participants per sequence. Each participant will complete three open-label treatment periods (Day 1, Day 4, and Day 7), with a 3-day washout period between periods. The selected KL0011034 dose from Part 1 will be used in Part 2. Pharmacokinetic sampling, pharmacodynamic evaluations, and safety assessments will be performed during each period. Participants will be discharged after the end-of-study examinations on Day 8 (D8).

Sequence A: Period 1: KL0011034 Injection (selected dose); Period 2: Alfentanil Hydrochloride Injection 5 μg/kg; Period 3: Alfentanil Hydrochloride Injection 5 μg/kg + KL0011034 Injection (selected dose).

Sequence B: Period 1: Alfentanil Hydrochloride Injection 5 μg/kg; Period 2: Alfentanil Hydrochloride Injection 5 μg/kg + KL0011034 Injection (selected dose); Period 3: KL0011034 Injection (selected dose).

Sequence C: Period 1: Alfentanil Hydrochloride Injection 5 μg/kg + KL0011034 Injection (selected dose); Period 2: KL0011034 Injection (selected dose); Period 3: Alfentanil Hydrochloride Injection 5 μg/kg.

Conditions: Chronic Pain
Being tested: KL0011034 injection, Alfentanil Hydrochloride Injection
Keywords: Drug-Drug Interaction, KL0011034, Alfentanil, Pharmacokinetics, Non-Cancer Chronic Pain
Medical subject headings: Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

KL0011034 injectionDrug
KL0011034 Injection is an investigational drug being studied for its analgesic properties in combination with alfentanil. It is administered via intravenous infusion. The dose levels evaluated are 0.3 mg/kg, 0.35 mg/kg, and 0.4 mg/kg in Part 1; the selected dose from Part 1 is used in Part 2.
Alfentanil Hydrochloride InjectionDrug
Alfentanil Hydrochloride Injection is an opioid analgesic administered via intravenous bolus at a fixed dose of 5 μg/kg. It is used alone and in combination with KL0011034 Injection to evaluate drug-drug interaction.

Study groups in NCT07751094
Study group	Role	What they receive
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. Receives: Drug: KL0011034 injection; Drug: Alfentanil Hydrochloride Injection
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. Receives: Drug: KL0011034 injection; Drug: Alfentanil Hydrochloride Injection
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. Receives: Drug: KL0011034 injection; Drug: Alfentanil Hydrochloride Injection
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. Receives: Drug: KL0011034 injection; Drug: Alfentanil Hydrochloride Injection
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. Receives: Drug: KL0011034 injection; Drug: Alfentanil Hydrochloride Injection
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. Receives: Drug: KL0011034 injection; Drug: Alfentanil Hydrochloride Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Plasma Concentration (Cmax) of KL0011034
Cmax of KL0011034 in plasma, determined by non-compartmental analysis of concentration-time data.
Measured: 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
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.
Measured: 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.
Maximum Plasma Concentration (Cmax) of Alfentanil
Cmax of Alfentanil in plasma, determined by non-compartmental analysis of concentration-time data.
Measured: 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 Last Quantifiable Concentration (AUC0-t) of KL0011034
AUC0-t of KL0011034 in plasma, determined by non-compartmental analysis using linear-log trapezoidal method.
Measured: 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
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.
Measured: 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
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.
Measured: 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
Area Under the Curve From Time Zero Extrapolated to Infinity (AUC0-∞) of KL0011034
AUC0-∞ of KL0011034 in plasma, calculated as AUC0-t + Clast/λz.
Measured: 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
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.
Measured: 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
Area Under the Curve From Time Zero Extrapolated to Infinity (AUC0-∞) of Alfentanil
AUC0-∞ of Alfentanil in plasma, calculated as AUC0-t + Clast/λz.
Measured: 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

Secondary outcomes (30)

Time to Maximum Plasma Concentration (Tmax) of KL0011034
Tmax of KL0011034 in plasma, determined directly from concentration-time data.
Measured: 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
Tmax of KL0011034 major metabolite A644S(A)-Z7 in plasma, determined directly from concentration-time data.
Measured: 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
Tmax of Alfentanil in plasma, determined directly from concentration-time data.
Measured: 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
AUC0-24h of KL0011034 in plasma, determined by non-compartmental analysis.
Measured: 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 KL0011034 Metabolite A644S(A)-Z7
AUC0-24h of KL0011034 major metabolite A644S(A)-Z7 in plasma, determined by non-compartmental analysis.
Measured: 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
AUC0-24h of Alfentanil in plasma, determined by non-compartmental analysis.
Measured: 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
Elimination half-life (t1/2) of KL0011034 in plasma, calculated as ln(2)/λz, where λz is the terminal elimination rate constant determined by log-linear regression of the terminal phase of the concentration-time curve. Unit: hours.
Measured: 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 KL0011034 Metabolite A644S(A)-Z7
Elimination half-life (t1/2) of KL0011034 major metabolite A644S(A)-Z7 calculated as ln(2)/λz, where λz is the terminal elimination rate constant determined by log-linear regression of the terminal phase.
Measured: 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
Elimination half-life (t1/2) of Alfentanil calculated as ln(2)/λz, where λz is the terminal elimination rate constant determined by log-linear regression of the terminal phase.
Measured: 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
Apparent volume of distribution (Vd) of KL0011034 calculated as Dose/(AUC0-∞ × λz).
Measured: 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
Apparent volume of distribution (Vd) of KL0011034 major metabolite A644S(A)-Z7 calculated as Dose/(AUC0-∞ × λz).
Measured: 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
Apparent volume of distribution (Vd) of Alfentanil calculated as Dose/(AUC0-∞ × λz).
Measured: 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
Total body clearance (CL) of KL0011034 calculated as Dose/AUC0-∞.
Measured: 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
Total body clearance (CL) of KL0011034 major metabolite A644S(A)-Z7 calculated as Dose/AUC0-∞.
Measured: 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
Total body clearance (CL) of Alfentanil calculated as Dose/AUC0-∞.
Measured: 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
Terminal elimination rate constant (λz) of KL0011034 determined by log-linear regression of the terminal phase of the concentration-time curve.
Measured: 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
Terminal elimination rate constant (λz) of KL0011034 major metabolite A644S(A)-Z7 determined by log-linear regression of the terminal phase of the concentration-time curve.
Measured: 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
Terminal elimination rate constant (λz) of Alfentanil determined by log-linear regression of the terminal phase of the concentration-time curve.
Measured: 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.
Mean Residence Time (MRT0-∞) of KL0011034
Mean residence time (MRT0-∞) of KL0011034 calculated as AUMC/AUC0-∞.
Measured: 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
Mean residence time (MRT0-∞) of KL0011034 major metabolite A644S(A)-Z7 calculated as AUMC/AUC0-∞.
Measured: 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 Alfentanil
Mean residence time (MRT0-∞) of Alfentanil calculated as AUMC/AUC0-∞.
Measured: 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.
Adverse Events and Serious Adverse Events
Incidence, severity, and causality of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) assessed by clinical observation and participant reporting.
Measured: 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
Change from baseline in vital signs including blood pressure, pulse rate, respiratory rate, tympanic temperature, and oxygen saturation (SpO2).
Measured: 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
Change from baseline in 12-lead ECG parameters including heart rate, PR interval, QRS interval, and QT interval corrected using Fridericia's formula (QTcF).
Measured: 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
Number of participants with clinically significant abnormalities in physical examination findings (skin, mucous membranes, lymph nodes, head, neck, chest, abdomen, spine/extremities, and nervous system), assessed by standard physical examination.
Measured: Part 2: Screening, Day -1, and Day 8 (end-of-study).
Injection Site Reactions
Incidence and severity of injection site reactions (pain, tenderness, erythema, and induration/swelling), assessed by physical examination of the injection site using a standardized assessment scale. Severity graded as mild, moderate, or severe.
Measured: 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
Sedation level assessed using the Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scale. Sedation onset defined as first MOAA/S score ≤4; recovery defined as MOAA/S score of 5 on 3 consecutive assessments.
Measured: 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
Continuous BIS monitoring to assess depth of sedation/anesthesia. Anesthesia onset defined as first BIS value ≤60; duration of BIS between 40 and 60 is recorded.
Measured: 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.
Eyelash Reflex
Time to loss of eyelash reflex and time to recovery of eyelash reflex after study drug administration.
Measured: 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
Recovery assessed using the Modified Aldrete Score (evaluating activity, respiration, blood pressure, consciousness, and SpO2). Discharge criteria met when score ≥9 on 3 consecutive assessments.
Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Jul 202631 Jul 2027

First posted7 Aug 2026
Study start30 Jul 2026 (estimated)
Primary completion31 Jul 2027 (estimated)
Study completion31 Jul 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Chronic PainStudies of the same condition, open and under way.
More trials run by The Third Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 27 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07751094
Sponsor's protocol ID: KL0011034-102
Status last verified: Aug 2026
First submitted: 6 Jul 2026
Last updated: 7 Aug 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Individual participant data (IPD) will not be shared because this is a first-in-human or early-stage clinical trial involving a novel investigational drug. The data contain proprietary and confidential information that could compromise ongoing patent applications and future commercial development. Public data sharing at this stage may also violate our confidentiality agreements with the contract research organization (CRO) and regulatory authorities. Therefore, IPD sharing is not feasible until the drug receives market approval or the primary study results are fully published.

Interested in taking part?

Huang Jie

+86 731 8991 8665

cellahuang1988@163.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
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Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
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What happens when the study ends?

See sites and contacts

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All Chronic Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT07751094
Acronym / sponsor ID: KL0011034-102
Conditions: Chronic Pain
Keywords: Drug-Drug Interaction, KL0011034, Alfentanil, Pharmacokinetics, Non-Cancer Chronic Pain
Phase: Phase 1
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 27 participants (estimated)
Lead sponsor: The Third Xiangya Hospital of Central South UniversityUniversity, hospital or other
Collaborators: Hunan Kelun Pharmaceutical Co., Ltd., Sichuan Kelun Pharmaceutical Co.,Ltd.
Study start: 30 Jul 2026 (estimated)
Primary completion: 31 Jul 2027 (estimated)
Study completion: 31 Jul 2027 (estimated)
First posted: 7 Aug 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study Design and Population:

Part 1 (Safety, Tolerability, and Pharmacodynamics):

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
1.Alfentanil 5 µg/kg + KL0011034 0.3 mg/kg	Experimental	Drug: KL0011034 injection, Drug: Alfentanil Hydrochloride InjectionPart 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.
2.Alfentanil 5 µg/kg + KL0011034 0.35 mg/kg	Experimental	Drug: KL0011034 injection, Drug: Alfentanil Hydrochloride InjectionPart 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.
3.Alfentanil 5 µg/kg + KL0011034 0.4 mg/kg	Experimental	Drug: KL0011034 injection, Drug: Alfentanil Hydrochloride InjectionPart 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.
4.Sequence A: KL0011034 → Alfentanil → Alfentanil + KL0011034	Experimental	Drug: KL0011034 injection, Drug: Alfentanil Hydrochloride InjectionPart 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.
5. Sequence B: Alfentanil → Alfentanil + KL0011034 → KL0011034	Experimental	Drug: KL0011034 injection, Drug: Alfentanil Hydrochloride InjectionPart 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.
6. Sequence C: Alfentanil + KL0011034 → KL0011034 → Alfentanil	Experimental	Drug: KL0011034 injection, Drug: Alfentanil Hydrochloride InjectionPart 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.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (28 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
KL0011034 injectionKL0011034 Injection is an investigational drug being studied for its analgesic properties in combination with alfentanil. It is administered via intravenous infusion. The dose levels evaluated are 0.3 mg/kg, 0.35 mg/kg, and 0.4 mg/kg in Part 1; the selected dose from Part 1 is used in Part 2.	Drug	1.Alfentanil 5 µg/kg + KL0011034 0.3 mg/kg, 2.Alfentanil 5 µg/kg + KL0011034 0.35 mg/kg, 3.Alfentanil 5 µg/kg + KL0011034 0.4 mg/kg, 4.Sequence A: KL0011034 → Alfentanil → Alfentanil + KL0011034, 5. Sequence B: Alfentanil → Alfentanil + KL0011034 → KL0011034, 6. Sequence C: Alfentanil + KL0011034 → KL0011034 → Alfentanil
Alfentanil Hydrochloride InjectionAlfentanil Hydrochloride Injection is an opioid analgesic administered via intravenous bolus at a fixed dose of 5 μg/kg. It is used alone and in combination with KL0011034 Injection to evaluate drug-drug interaction.	Drug	1.Alfentanil 5 µg/kg + KL0011034 0.3 mg/kg, 2.Alfentanil 5 µg/kg + KL0011034 0.35 mg/kg, 3.Alfentanil 5 µg/kg + KL0011034 0.4 mg/kg, 4.Sequence A: KL0011034 → Alfentanil → Alfentanil + KL0011034, 5. Sequence B: Alfentanil → Alfentanil + KL0011034 → KL0011034, 6. Sequence C: Alfentanil + KL0011034 → KL0011034 → Alfentanil

Primary outcome

Maximum Plasma Concentration (Cmax) of KL0011034
Time frame: 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
Time frame: 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.
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
Time frame: 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
Time frame: 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-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
Time frame: 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-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
Time frame: 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-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
Time frame: 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 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
Time frame: 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 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
Time frame: 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.

30 secondary outcomes

Time to Maximum Plasma Concentration (Tmax) of KL0011034
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 KL0011034 Metabolite A644S(A)-Z7
Time frame: 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
Time frame: 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
Time frame: 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 KL0011034 Metabolite A644S(A)-Z7
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Mean Residence Time (MRT0-∞) of KL0011034
Time frame: 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
Time frame: 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 Alfentanil
Time frame: 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.
Adverse Events and Serious Adverse Events
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Part 2: Screening, Day -1, and Day 8 (end-of-study).
Injection Site Reactions
Time frame: 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
Time frame: 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
Time frame: 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.
Eyelash Reflex
Time frame: 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
Time frame: 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.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because this is a first-in-human or early-stage clinical trial involving a novel investigational drug. The data contain proprietary and confidential information that could compromise ongoing patent applications and future commercial development. Public data sharing at this stage may also violate our confidentiality agreements with the contract research organization (CRO) and regulatory authorities. Therefore, IPD sharing is not feasible until the drug receives market approval or the primary study results are fully published.

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Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Huang Jie contact

+86 731 8991 8665

cellahuang1988@163.com

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing KL0011034 injection and Alfentanil Hydrochloride Injection in people with Chronic Pain, run by The Third Xiangya Hospital of Central South University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Huang Jie (+86 731 8991 8665, cellahuang1988@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Plasma Concentration (Cmax) of KL0011034 (time frame: 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). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07751094.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.