Clinical Trials in China / NCT07171034
Recruiting
Phase 1
A Phase I Study of KLA318-2 Nanocrystal Injection
NCT07171034 · tracked via the Priya Life Science China tracker
Condition(s) studied
Healthy Participants
Investigational drug(s) / intervention(s)
KLA318-2 Nanocrystal InjectionCelebrex Capsule →
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
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 |
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Official registry record
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.
View NCT07171034 on ClinicalTrials.gov ↗ ← All trials in China