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Clinical Trials in China / NCT07710560
Completed Phase 1

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

NCT07710560 · tracked via the Priya Life Science China tracker
Sponsor
Hunan Kelun Pharmaceutical Co., Ltd.
Phase
Phase 1
Started
2026-07-15
Last updated
2026-09-17

Condition(s) studied

Chronic Pain

Investigational drug(s) / intervention(s)

KL0011034 injectionAlfentanil Hydrochloride Injection

KL0011034 injection: Intravenous injection, single dose

Alfentanil Hydrochloride Injection: Intravenous injection, single dose

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
55 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
The Third XIANGYA Hospital of Central South University Changsha Hunan

More Hunan Kelun Pharmaceutical Co., Ltd. trials in China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07710560 on ClinicalTrials.gov ↗ ← All trials in China