A Phase I Study of KLA318-2 Nanocrystal Injection

Kelun Pharmaceutical

Status and phase: Enrolling; Phase 1

Conditions: Healthy Participants

Treatments: Drug: Celebrex Capsule; Drug: KLA318-2 Nanocrystal Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT07171034

KLA318-2-101

Details and patient eligibility

About

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.

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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48 participants in 4 patient groups

KLA318-2 Nanocrystal Injection 60mg

Experimental group

Description:

12 participants receive KLA318-2 60mg

Treatment:

Drug: KLA318-2 Nanocrystal Injection

KLA318-2 Nanocrystal Injection 120mg

Active Comparator group

Description:

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

Treatment:

Drug: KLA318-2 Nanocrystal Injection

Drug: Celebrex Capsule

KLA318-2 Nanocrystal Injection 180mg

Active Comparator group

Description:

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

Treatment:

Drug: KLA318-2 Nanocrystal Injection

Drug: Celebrex Capsule

KLA318-2 Nanocrystal Injection 240mg

Experimental group

Description:

12 participants receive KLA318-2 240mg

Treatment:

Drug: KLA318-2 Nanocrystal Injection