Starting soon
Phase 1
A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of KL0011034 Injection Administered by Continuous Infusion in Healthy Adult Subjects
Condition(s) studied
Healthy Volunteers
Investigational drug(s) / intervention(s)
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
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)
- Number of reported Adverse Events — 24 hours post-dose
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 |
|
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