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NCT Number: NCT07171034

A Phase I Study of KLA318-2 Nanocrystal Injection

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The first affiliated hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital)

Jinan, Shandong, 250014, China

Location status: Recruiting

Location contact

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

KLA318-2 Nanocrystal Injection

Drug

Intravenous injection, single dose

Celebrex Capsule

Drug

P.O., single dose

Primary outcomes

  1. Incidence and severity of adverse events (AEs)

    Time frame: UP to Day 14

Secondary outcomes

  1. PK parameter Cmax

    Time frame: UP to Day 3

    Maximum peak plasma concentration (Cmax) after single dose and in a steady state after multiple doses

  2. PK parameter Tmax

    Time frame: UP to Day 3

    Time of Cmax (Tmax) after single dose and in a steady state after multiple doses

  3. PK parameter AUC0-t

    Time frame: UP to Day 3

    Area under the concentration-time curve (AUC0-t) from time zero to time "t" after single dose and in a steady state after multiple doses

  4. PK parameter AUC0-∞

    Time frame: UP to Day 3

    AUC from time zero to infinity (AUC0-∞) after single dose and in a steady state after multiple doses

  5. PK parameter t1/2

    Time frame: UP to Day 3

    Terminal-phase elimination half-life (t1/2) after single dose and in a steady state after multiple doses

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Hunan Kelun Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of KLA318-2 Nanocrystal Injection in Healthy Participants

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 12, 2025
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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