Status:
RECRUITING
A Phase I Study of KLA318-2 Nanocrystal Injection
Lead Sponsor:
Hunan Kelun Pharmaceutical Co., Ltd.
Conditions:
Healthy Participants
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief 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 Criteria
Inclusion
- Health participants (Age: 18\~45 years);
- Body Weight: Male≥50.0kg, Female≥45.0kg; 18.5 ≤BMI≤ 28.0;
- Normal ECG, showing no clinically relevant deviations, as judged by the investigator.
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2026
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT07171034
Start Date
September 1 2025
End Date
May 31 2026
Last Update
November 17 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The first affiliated hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital)
Jinan, Shandong, China, 250014