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.
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;
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;
Crossover
KL0011034 injection
DrugKL0011034 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 Injection
DrugAlfentanil 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.
6
Treatment groupsSee each treatment group below.
Maximum Plasma Concentration (Cmax) of KL0011034
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
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.
Time to Maximum Plasma Concentration (Tmax) of KL0011034
Tmax of KL0011034 in plasma, determined directly from concentration-time data.
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.
Time to Maximum Plasma Concentration (Tmax) of Alfentanil
Tmax of Alfentanil in plasma, determined directly from concentration-time data.
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.
Click on the lead sponsor to view all of their trials.
The Third Xiangya Hospital of Central South University
Lead sponsor
Hunan Kelun Pharmaceutical Co., Ltd.
Collaborator
Sichuan Kelun Pharmaceutical Co.,Ltd.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
