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)
Number of reported Adverse Events — 24 hours post-dose for each period Safety and tolerability was assessed by the number of volunteers with adverse events.
Trial sites (1)
Facility
City
Region
Status
The Third XIANGYA Hospital of Central South University
Changsha
Hunan
More Hunan Kelun Pharmaceutical Co., Ltd. trials in China
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.
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