A Phase I Study of KLA318-2 Nanocrystal Injection

A Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of KLA318-2 Nanocrystal Injection in Healthy Participants

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.

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.