NCT07171034

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 12, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2026

Completed
Last Updated

May 26, 2026

Status Verified

May 1, 2026

Enrollment Period

9 months

First QC Date

August 28, 2025

Last Update Submit

May 21, 2026

Conditions

Healthy Participants

Keywords

Healthy

Outcome Measures

Primary Outcomes (1)

  • Incidence and severity of adverse events (AEs)

    UP to Day 14

Secondary Outcomes (5)

  • PK parameter Cmax

    UP to Day 3

  • PK parameter Tmax

    UP to Day 3

  • PK parameter AUC0-t

    UP to Day 3

  • PK parameter AUC0-∞

    UP to Day 3

  • PK parameter t1/2

    UP to Day 3

Study Arms (4)

KLA318-2 Nanocrystal Injection 60mg

EXPERIMENTAL

12 participants receive KLA318-2 60mg

Drug: KLA318-2 Nanocrystal Injection

KLA318-2 Nanocrystal Injection 120mg

ACTIVE COMPARATOR

Period 1, 6 participants receive KLA318-2 120mg → 6 participants receive Celebrex Capsule 200mg; Period 2, 6 participants receive Celebrex Capsule 200mg → 6 participants receive KLA318-2 120mg

Drug: KLA318-2 Nanocrystal InjectionDrug: Celebrex Capsule

KLA318-2 Nanocrystal Injection 180mg

ACTIVE COMPARATOR

Period 1, 6 participants receive KLA318-2 180mg → 6 participants receive Celebrex Capsules 400mg; Period 2, 6 participants receive Celebrex Capsules 400mg → 6 participants receive KLA318-2 180mg

Drug: KLA318-2 Nanocrystal InjectionDrug: Celebrex Capsule

KLA318-2 Nanocrystal Injection 240mg

EXPERIMENTAL

12 participants receive KLA318-2 240mg

Drug: KLA318-2 Nanocrystal Injection

Interventions

KLA318-2 Nanocrystal InjectionDRUG

Intravenous injection, single dose

KLA318-2 Nanocrystal Injection 120mgKLA318-2 Nanocrystal Injection 180mgKLA318-2 Nanocrystal Injection 240mgKLA318-2 Nanocrystal Injection 60mg
Celebrex CapsuleDRUG

P.O., single dose

KLA318-2 Nanocrystal Injection 120mgKLA318-2 Nanocrystal Injection 180mg

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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;
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Jinan, Shandong, 250014, China

RECRUITING

MeSH Terms

Interventions

Celecoxib

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Central Study Contacts

Wei Qi

CONTACT

028-82339360qiw@kelun.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2025

First Posted

September 12, 2025

Study Start

September 1, 2025

Primary Completion

May 31, 2026

Study Completion

May 31, 2026

Last Updated

May 26, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)