Single-dose KLA318-2 nanocrystal injection safety and PK test

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase I, interventional study enrolls healthy volunteers aged 18–45 to receive a single intravenous injection of KLA318-2 nanocrystal and follow them for safety, tolerability, and pharmacokinetics. Staff will collect serial blood samples and monitor vital signs, ECG, and adverse events to characterize how the drug is absorbed, distributed, and cleared. The interventions list also includes a celecoxib (Celebrex) capsule, suggesting the protocol may include co-administration or interaction checks with celecoxib. Standard exclusion criteria (recent medications, surgeries, vaccines, substance use, or significant medical history) are applied to minimize risk and confounding factors.

Why it matters

Who can join: the full rules

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.

Where it's running

• The first affiliated hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital)
  Jinan, Shandong, China Recruiting

Study contacts

• Study coordinator: Wei Qi
• Email: qiw@kelun.com
• Phone: 028-82339360

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.