A Phase I Study of KLA318-2 Nanocrystal Injection

Recruiting now · Phase 1

Conditions studied: Healthy Participants

In brief

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.

Key facts

Study ID

NCT07171034

Run by

Hunan Kelun Pharmaceutical Co., Ltd.

People needed

48

Starts

2025-09-01

Expected to finish

2026-05-31

Last updated by the study team

2026-05-26

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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