A Phase I Study of KLA318-2 Nanocrystal Injection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-01

Study Completion Date

2026-05-31

Brief Summary

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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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Detailed Description

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Conditions

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Healthy Participants

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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KLA318-2 Nanocrystal Injection 60mg

12 participants receive KLA318-2 60mg

Group Type EXPERIMENTAL

KLA318-2 Nanocrystal Injection

Intervention Type DRUG

Intravenous injection, single dose

KLA318-2 Nanocrystal Injection 120mg

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

Group Type ACTIVE_COMPARATOR

KLA318-2 Nanocrystal Injection

Intervention Type DRUG

Intravenous injection, single dose

Celebrex Capsule

Intervention Type DRUG

P.O., single dose

KLA318-2 Nanocrystal Injection 180mg

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

Group Type ACTIVE_COMPARATOR

KLA318-2 Nanocrystal Injection

Intervention Type DRUG

Intravenous injection, single dose

Celebrex Capsule

Intervention Type DRUG

P.O., single dose

KLA318-2 Nanocrystal Injection 240mg

12 participants receive KLA318-2 240mg

Group Type EXPERIMENTAL

KLA318-2 Nanocrystal Injection

Intervention Type DRUG

Intravenous injection, single dose

Interventions

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KLA318-2 Nanocrystal Injection

Intravenous injection, single dose

Intervention Type DRUG

Celebrex Capsule

P.O., single dose

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes