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A Phase I Study of KLA318-2 Nanocrystal Injection

A Phase I Study of KLA318-2 Nanocrystal Injection

Recruiting
18-45 years
All
Phase 1

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Overview

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.

Study details
    Healthy Participants

NCT07171034

Hunan Kelun Pharmaceutical Co., Ltd.

31 January 2026

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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