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Recruiting Phase 1

First-in-Human Single and Multiple Dose of KLA578-1 for Injection

NCT07143318 · tracked via the Priya Life Science China tracker
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)

  • Incidence and severity of adverse events (AEs) — Up to day 13

Trial sites (1)

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