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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
Sponsor
Hunan Kelun Pharmaceutical Co., Ltd.
Phase
Phase 1
Started
2025-09-01
Last updated
2026-05-26

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

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)

Trial sites (1)

FacilityCityRegionStatus
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

Other trials for the same condition

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