A Phase I Study of KLA318-2 Nanocrystal Injection

Exclusion Criteria18

• Allergy or Drug hypersensitivity;
• Clinically significant Medical History;
• Gastrointestinal ulcers or gastrointestinal bleeding;
• History of any surgery within 4 weeks;
• History of any Medication within 14 days;
• History of any drug interactions with celecoxib within 30 days;
• History of any clinical study within 3 months;
• History of any vaccine within 1 month;
• History of any drug abuse, or positive drugs of abuse test result;
• Subjects with difficult venous blood collection/intolerance to venipuncture, or with a history of needle phobia/blood phobia;
• Massive blood loss (> 200 mL) in the past 3 months;
• Special requirements for diet;
• Heavy smoker ( more than 3 cigarettes/day) within 3 months;
• History of alcohol abuse,or heavy alcohol intake (more than 14 units a week) within 6 months, or positive alcohol test;
• Heavy caffeine intake;
• History of grapefruit, xanthine-rich foods intake within 7 days;
• Female participants are pregnant or lactating;
• History of unprotected sex within 2 weeks.