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Clinical Trials in China / NCT07828470
Starting soon Phase 1

A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of KL0011034 Injection Administered by Continuous Infusion in Healthy Adult Subjects

NCT07828470 · tracked via the Priya Life Science China tracker
Sponsor
Hunan Kelun Pharmaceutical Co., Ltd.
Phase
Phase 1
Started
2026-10-13
Last updated
2026-09-18

Condition(s) studied

Healthy Volunteers

Investigational drug(s) / intervention(s)

KL0011034 injectionpropofol injectable emulsion

KL0011034 injection: Intravenous injection, continuous infusion

propofol injectable emulsion: Intravenous injection, continuous infusion

Study summary

This study is a randomized, double-blind, propofol position-controlled trial, evaluating the safety, tolerability, and pharmacodynamic of continuous infusion of KL0011034 injection compared with propofol injectable emulsion for durations of 1 hour, 2 hours, and 3 hours, and evaluating the pharmacokinetic of the KL0011034 injection.

Eligibility

Sex
ALL
Min age
18 Years
Max age
45 Years
Healthy volunteers
Accepted
Inclusion Criteria: 1. Sign the informed consent form 2. Health participants (Age: 18\~45 years); 3. Body Weight: Male≥50.0kg, Female≥45.0kg; 19 ≤BMI≤ 26.0kg/m2; 4. There were no abnormalities in clinically significant physical examination, vital signs, 12-lead electrocardiogram, chest x-ray, abdominal B-ultrasound, laboratory tests; 5. Agreed to use contraception for 3 months post-dose. 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 clinical study within 3 months; 10. History of any vaccine within 1 month; 11. History of any drug abuse; 12. Needle sickness, Hematosickness; 13. Massive blood loss (\> 400 mL) in the past 3 months; 14. Female volunteers are pregnant or lactating; 15. History of unprotected sex within 2 weeks; 16. Heavy smoker ( more than 5 cigarettes/day) within 3 months; 17. History of alcohol abuse,or heavy alcohol intake (more than 14 units a week) within 6 months; 18. Heavy caffeine intake; 19. History of grapefruit, xanthine-rich foods intake within 48 hours; 20. Positive alcohol test; 21. Positive nicotine test; 22. 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

Other trials for the same condition

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 NCT07828470 on ClinicalTrials.gov ↗ ← All trials in China