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

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

To evaluate the pharmacokinetic interaction of KL0011034 injection in combination with alfentanil hydrochloride injection.To evaluate the safety and tolerability of KL0011034 injection in combination with alfentanil hydrochloride injection.To evaluate the effect of alfentanil hydrochloride injection on the pharmacodynamics of KL0011034 injection.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Pain
• Intervention / Treatment: Drug: KL0011034 injection; Drug: Alfentanil Hydrochloride Injection

Detailed Description

This study will be conducted among the participants with moderate-to-severe non-cancerous chronic pain, aiming to evaluate the drug-drug interactions between KL0011034 injection and alfentanil hydrochloride injection. The study consists of two parts:

Part 1 trial:

A single-center, randomized, open, parallel design is adopted to evaluate the safety, tolerability and pharmacodynamic characteristics of the combined use of KL0011034 injection and alfentanil hydrochloride injection.

It is planned to enroll 9 patients with moderate-to-severe non-cancerous chronic pain. All participants will be randomly assigned to one of the three dose groups in a 1:1:1 ratio, with 3 participants in each group. They will complete a single combined administration and undergo pharmacodynamic and safety evaluations.

Based on the results of Part 1 trial, KL0011034 injection will select the maximum dose with acceptable safety among the three doses for the second part of the study.

Part 2 trial:

A single-center, randomized, open, three-sequence, three-period crossover trial design is adopted to evaluate the PK interactions, safety and tolerability of the combined use of KL0011034 injection and alfentanil hydrochloride injection, as well as the effect of alfentanil hydrochloride injection on the pharmacodynamics of KL0011034 injection.

It is planned to enroll 18 patients with moderate-to-severe non-cancerous chronic pain. All participants will be randomly assigned to one of the three sequences A, B, and C in a 1:1:1 ratio, with 6 participants in each sequence. They will complete three periods of open administration and undergo PK blood sampling, pharmacodynamic and safety evaluations, with a 3-day washout period for each period.

• Study Type: Interventional
• Enrollment (Estimated): 27
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Wei Qi; Phone Number: 028-82339360; Email: qiw@kelun.com

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410205
      • The Third Xiangya Hospital of Central South University
      • Contact: Guoping Yang; Phone Number: 13974817168; Email: ygp9880@163.com
      • Contact: Saiying Wang; Phone Number: 0731-88618150; Email: 1771303488@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. patients with moderate-to-severe non-cancerous chronic pain (Age: 18~55 years, NRS score≥4);
2. Body Weight: Male≥50.0kg, Female≥45.0kg; 19.0 ≤BMI≤ 26.0;
3. There were no abnormalities in clinically significant physical examination, vital signs, 12-lead electrocardiogram, chest x-ray, abdominal B-ultrasound, laboratory tests;

Exclusion Criteria:

1. Allergy or Drug hypersensitivity;
2. Clinically significant Medical History;
3. History of anesthesia accident, history of serious adverse reactions of anesthesia, or family history of anesthesia accidents, or contraindications to general anesthesia;
4. Dyspnoea or suspected difficult airway, or predicting difficult endotracheal intubation;
5. History of bronchial asthma, chronic obstructive pulmonary disease, sleep apnea syndrome;
6. History of adrenal insufficiency or adrenal tumor or hereditary heme biosynthesis disorder or hereditary acute porphyria;
7. History of any surgery within 3 months;
8. History of any Medication within 14 days;
9. History of any inducers or inhibitors of CYP3A4 or CYP2C19 enzymes within 30 days;
10. History of any clinical study within 3 months;
11. History of any vaccine within 1 month;
12. History of any drug abuse;
13. Needle sickness, Hematosickness;
14. Massive blood loss (> 400 mL) in the past 3 months;
15. Female volunteers are pregnant or lactating;
16. History of unprotected sex within 2 weeks;
17. Heavy smoker ( more than 5 cigarettes/day) within 3 months;
18. History of alcohol abuse,or heavy alcohol intake (more than 14 units a week) within 6 months;
19. Heavy caffeine intake;
20. History of grapefruit, xanthine-rich foods intake within 48 hours;
21. Positive alcohol test;
22. Positive nicotine test;
23. Positive drugs of abuse test result.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence A; Period 1, 6 participants will receive KL0011034 injection; Period 2, 6 participants will receive Alfentanil Hydrochloride Injection; Period 3, 6 participants will receive combination of Alfentanil Hydrochloride Injection and KL0011034 injection	Drug: KL0011034 injection; Intravenous injection, single dose; Drug: Alfentanil Hydrochloride Injection; Intravenous injection, single dose
Experimental: Sequence B; Period 1, 6 participants will receive Alfentanil Hydrochloride Injection; Period 2, 6 participants will receive combination of Alfentanil Hydrochloride Injection and KL0011034 injection; Period 3, 6 participants will receive KL0011034 injection;	Drug: KL0011034 injection; Intravenous injection, single dose; Drug: Alfentanil Hydrochloride Injection; Intravenous injection, single dose
Experimental: Sequence C; Period 1, 6 participants will receive combination of Alfentanil Hydrochloride Injection and KL0011034 injection; Period 2, 6 participants will receive KL0011034 injection; Period 3, 6 participants will receive Alfentanil Hydrochloride Injection;	Drug: KL0011034 injection; Intravenous injection, single dose; Drug: Alfentanil Hydrochloride Injection; Intravenous injection, single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of reported Adverse Events	Safety and tolerability was assessed by the number of volunteers with adverse events.	24 hours post-dose for each period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PK parameter Cmax in plasma	Maximum peak plasma concentration (Cmax) of KL0011034 and its metabolite combining with or without Alfentanil Hydrochloride Injection. Cmax of Alfentanil combining with or without KL0011034 injection.	24 hours post-dose for each period
PK parameter Tmax in plasma	Time of Cmax (Tmax) of KL0011034 and its metabolite combining with or without Alfentanil Hydrochloride Injection. Tmax of Alfentanil combining with or without KL0011034 injection.	24 hours post-dose for each period
PK parameter AUC0-t in plasma	Area under the concentration-time curve (AUC0-t) from time zero to time "t" of KL0011034 and its metabolite combining with or without Alfentanil Hydrochloride Injection. AUC0-t of Alfentanil combining with or without KL0011034 injection.	24 hours post-dose for each period
PK parameter AUC0-∞ in plasma	AUC from time zero to infinity (AUC0-∞) of KL0011034 and its metabolite combining with or without Alfentanil Hydrochloride Injection. AUC0-∞ of Alfentanil combining with or without KL0011034 injection.	24 hours post-dose for each period
PK parameter t1/2 in plasma	Terminal-phase elimination half-life (t1/2) of KL0011034 and its metabolite combining with or without Alfentanil Hydrochloride Injection. t1/2 of Alfentanil combining with or without KL0011034 injection.	24 hours post-dose for each period
Modified Observer's Assessment of Alertness Sedation (MOAA/S) scale	MOAA/S is a commonly used clinical sedation assessment scale, ranging from 0 to 5, which helps clinicians determine the level of sedation in patients. A score of 5 indicates full consciousness, whereas a score of 0 indicates deep coma. Lower scores correspond to deeper levels of sedation.	Day 1 for each period
Electroencephalogram bispectrality index (BIS) monitoring	BIS is the most widely used method for the continuous monitoring of sedation depth in clinical anesthesia. BIS values range from 0 to 100, where 100 represents complete wakefulness and 0 indicates complete cortical electrical inhibition.	Day 1 for each period
Loss of eyelash reflex	The eyelash reflex is a commonly used clinical method to assess the level of consciousness in patients. Gentle stimulation of the eyelashes with a cotton swab normally elicits a blink; absence of this response indicates loss of the eyelash reflex.	Day 1 for each period
Modified Aldrete Scoring (Aldrete) Scale	The Modified Aldrete Score is the most widely used standardized tool for assessing discharge readiness from post-anesthesia care unit (PACU). It evaluates five parameters: activity, respiration, blood pressure consciousness, and SpO₂. Ranging from 0 to 10, the higher the score, the better the quality of recovery.	Day 1 for each period

Collaborators and Investigators

• Sponsor: Hunan Kelun Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): July 15, 2026
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: July 5, 2026
• First Submitted That Met QC Criteria: July 13, 2026
• First Posted (Actual): July 17, 2026

Study Record Updates

• Last Update Posted (Actual): July 17, 2026
• Last Update Submitted That Met QC Criteria: July 13, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: chronic pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Chronic Pain; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperidines; Fentanyl; Alfentanil
• Other Study ID Numbers: KL0011034-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No