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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
Sponsor
Hunan Kelun Pharmaceutical Co., Ltd.
Phase
Phase 1
Started
2025-06-05
Last updated
2026-05-26

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

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)

Trial sites (1)

FacilityCityRegionStatus
The Third Xiangya Hospital of Central South University Changsha Hunan Recruiting

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 NCT07143318 on ClinicalTrials.gov ↗ ← All trials in China