KLA578-1 for injection: Intravenous injection, single dose
Etopcoxib Tablets: P.O., single dose
Study summary
The purpose of this study is to evaluate the safety and tolerability and pharmacokinetics of single and multiple doses of KLA578-1 for injection in healthy volunteers
Eligibility
Sex
ALL
Min age
18 Years
Max age
45 Years
Healthy volunteers
Accepted
Inclusion Criteria:
1. Health Volunteers (Age: 18\~45 years);
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, laboratory tests;
4. Heart rate ≥ 60 bpm and pulse ≥ 60 beats/min.
Exclusion Criteria:
1. Allergy or Drug hypersensitivity;
2. Clinically significant Medical History;
3. Gastrointestinal ulcers or gastrointestinal bleeding;
4. History of any surgery within 4 weeks;
5. History of any Medication within 14 days;
6. History of any inducers or inhibitors of major CYP450 enzymes within 30 days;
7. History of any clinical study within 3 months;
8. History of any vaccine within 1 month;
9. History of any drug abuse;
10. Tablet dysphagia;
11. Needle sickness, Hematosickness;
12. Massive blood loss (\> 200 mL) in the past 3 months;
13. Female volunteers are pregnant or lactating;
14. History of unprotected sex within 2 weeks;
15. Special requirements for diet;
16. Heavy smoker ( more than 3 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 7 days;
20. Positive alcohol test;
21. Positive drugs of abuse test result.
Primary outcome measure(s)
Incidence and severity of adverse events (AEs) — Up to day 13
Trial sites (1)
Facility
City
Region
Status
The Third Xiangya Hospital of Central South University
Changsha
Hunan
Recruiting
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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