A Phase I Study of KLA318-2 Nanocrystal Injection

Not Applicable

Not yet recruiting

• Conditions: Healthy Participants
• Interventions: Drug: KLA318-2 Nanocrystal Injection; Drug: Celebrex Capsule

• Registration Number: NCT07171034
• Lead Sponsor: Hunan Kelun Pharmaceutical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-08-28
• Status Verified: 2025-09
• Study Start: 2025-09-01
• Study First Submitted QC: 2025-09-05
• Last Update Submitted: 2025-09-05
• Study First Posted: 2025-09-12
• Last Update Posted: 2025-09-12
• Primary Completion: 2026-05-31
• Study Completion: 2026-05-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
KLA318-2 Nanocrystal Injection 60mg	KLA318-2 Nanocrystal Injection	12 participants receive KLA318-2 60mg
KLA318-2 Nanocrystal Injection 120mg	KLA318-2 Nanocrystal Injection	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
KLA318-2 Nanocrystal Injection 180mg	KLA318-2 Nanocrystal Injection	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
KLA318-2 Nanocrystal Injection 120mg	Celebrex Capsule	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
KLA318-2 Nanocrystal Injection 180mg	Celebrex Capsule	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
KLA318-2 Nanocrystal Injection 240mg	KLA318-2 Nanocrystal Injection	12 participants receive KLA318-2 240mg

Primary Outcome Measures

Name	Time	Method
Incidence and severity of adverse events (AEs)	UP to Day 14

Secondary Outcome Measures

Name	Time	Method
PK parameter Cmax	UP to Day 3	Maximum peak plasma concentration (Cmax) after single dose and in a steady state after multiple doses
PK parameter Tmax	UP to Day 3	Time of Cmax (Tmax) after single dose and in a steady state after multiple doses
PK parameter AUC0-t	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
PK parameter AUC0-∞	UP to Day 3	AUC from time zero to infinity (AUC0-∞) after single dose and in a steady state after multiple doses
PK parameter t1/2	UP to Day 3	Terminal-phase elimination half-life (t1/2) after single dose and in a steady state after multiple doses

Trial Locations

Locations (1)

The first affiliated hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital); 🇨🇳 Jinan, Shandong, China