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

Starting soon · Phase 1

Conditions studied: Chronic Pain

In brief

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.

Key facts

Study ID

NCT07710560

Run by

Hunan Kelun Pharmaceutical Co., Ltd.

People needed

27

Starts

2026-07-15

Expected to finish

2026-07-31

Last updated by the study team

2026-07-17

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• The Third XIANGYA Hospital of Central South University — Changsha, Hunan, China

Full record on ClinicalTrials.gov

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