A Phase I Study of KLA318-2 Nanocrystal Injection
Trial Parameters
Brief Summary
The purpose of this study is to evaluate the safety,tolerability and pharmacokinetics properties of KLA318-2 Nanocrystal Injection after a single intravenous injection in healthy participants.
Eligibility Criteria
Inclusion Criteria: 1. Health participants (Age: 18\~45 years); 2. Body Weight: Male≥50.0kg, Female≥45.0kg; 18.5 ≤BMI≤ 28.0; 3. Normal ECG, showing no clinically relevant deviations, as judged by the investigator. 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 drug interactions with celecoxib 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, or positive drugs of abuse test result; 10. Subjects with difficult venous blood collection/intolerance to venipuncture, or with a history of needle phobia/blood phobia; 11. Massive blood loss (\> 200 mL) in the past 3 months; 12. Special requirements for diet; 13. Heavy smoker ( more than 3 cigarettes/day) within 3 months; 14. History of alcohol abus