KLA318-2 Nanocrystal Injection: Intravenous injection, single dose
Celebrex Capsule: P.O., single dose
Study 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
Sex
ALL
Min age
18 Years
Max age
45 Years
Healthy volunteers
Accepted
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.
Primary outcome measure(s)
Incidence and severity of adverse events (AEs) — UP to Day 14
Trial sites (1)
Facility
City
Region
Status
The first affiliated hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital)
Jinan
Shandong
Recruiting
More Hunan Kelun Pharmaceutical Co., Ltd. trials in China
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.
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