Clinical Trials in China / NCT07143318
Recruiting
Phase 1
First-in-Human Single and Multiple Dose of KLA578-1 for Injection
NCT07143318 · tracked via the Priya Life Science China tracker
Condition(s) studied
Healthy Volunteers
Investigational drug(s) / intervention(s)
KLA578-1 for injectionEtopcoxib Tablets
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
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
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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 NCT07143318 on ClinicalTrials.gov ↗ ← All trials in China