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.
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Maximum Plasma Concentration (Cmax) of KL0011034
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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