A Phase I Study of KLA318-2 Nanocrystal Injection

• KLA318-2 Nanocrystal Injection (Drug): Intravenous injection, single dose
• Celebrex Capsule (Drug): P.O., single dose

Primary outcomes

• Incidence and severity of adverse events (AEs) [UP to Day 14]

Secondary outcomes

• PK parameter Cmax [UP to Day 3]: Maximum peak plasma concentration (Cmax) after single dose and in a steady state after multiple doses
• PK parameter Tmax [UP to Day 3]: Time of Cmax (Tmax) after single dose and in a steady state after multiple doses
• PK parameter AUC0-t [UP to Day 3]: Area under the concentration-time curve (AUC0-t) from time zero to time "t" after single dose and in a steady state after multiple doses
• PK parameter AUC0-∞ [UP to Day 3]: AUC from time zero to infinity (AUC0-∞) after single dose and in a steady state after multiple doses
• PK parameter t1/2 [UP to Day 3]: Terminal-phase elimination half-life (t1/2) after single dose and in a steady state after multiple doses

Sex: All, ages: 18 Years to 45 Years, accepts healthy volunteers

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 abuse,or heavy alcohol intake (more than 14 units a week) within 6 months, or positive alcohol test;
15. Heavy caffeine intake;
16. History of grapefruit, xanthine-rich foods intake within 7 days;
17. Female participants are pregnant or lactating;
18. History of unprotected sex within 2 weeks.