First-in-Human Single and Multiple Dose of KLA578-1 for Injection

NCT ID: NCT07143318

Last Updated: 2025-08-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-05
• Study Completion Date: 2026-05-31

Brief Summary

The purpose of this study is to evaluate the safety and tolerability and pharmacokinetics of single and multiple doses of KLA578-1 for injection in healthy volunteers

Detailed Description

"The study will be carried out in 2 parts. Part 1: This is a open-label, single ascending dose (SAD) escalation study with a total of 3 dose groups, i.e., Groups 1 to 3. There are a total of 12 volunteers in each group with a similar male to female ratio. Groups 1 and 3 are single-arm study, all volunteers will receive the experimental drug ""KLA578-1 for Injection"" ; Group 2 is a randomized, two-treatment, two-period, crossover study, 12 volunteers will be randomized to TR sequence or RT sequence with 6 volunteers in each sequence. The experimental drug ""KLA578-1 for injection"" will be administered in the TR sequence of Period 1, the control drug ""Etopcoxib Tablets"" will be administered to the RT sequence. After 7 days of washing, the control drug ""Etocoxib Tablets"" will be administered in the TR sequence, and the experimental drug ""KLA578-1 for Injection"" will be administered in the RT sequence.

Part 2: This is a open-label, single-arm multiple dose study. A dose group is temporarily set up, with a total of 12 volunteers enrolled, and the male-to-female ratio will be similar. Volunteers will receive the experimental drug ""KLA578-1 for Injection"" 120 mg once daily (every 24 h ± 2 min with reference to the dosing time on D1) under fasting conditions (fasting for at least 10 hours) from D1 to D5; Drinking water is prohibited from 1 h before each dose to 1 h postdose, and fasted within 4 hours after dosing on D1 and D5."

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

KLA578-1 60mg

12 volunteers receive KLA578-1 for injection 60mg

Group Type: EXPERIMENTAL

KLA578-1 for injection

Intervention Type: DRUG

Intravenous injection, single dose

KLA578-1 120mg

Period 1, 6 volunteers receive KLA578-1 for injection 120mg → 6 volunteers receive Etopcoxib Tablets 120mg; Period 2, 6 volunteers receive Etopcoxib Tablets 120mg → 6 volunteers receive KLA578-1 for injection 120mg

Group Type: ACTIVE_COMPARATOR

KLA578-1 for injection

Intervention Type: DRUG

Intravenous injection, single dose

Etopcoxib Tablets

Intervention Type: DRUG

P.O., single dose

KLA578-1 240mg

12 volunteers receive KLA578-1 for injection 240mg

Group Type: EXPERIMENTAL

KLA578-1 for injection

Intervention Type: DRUG

Intravenous injection, single dose

multiple doses of KLA578-1 for injection

12 volunteers receive KLA578-1 for injection 120mg over 5 consecutive days.

Group Type: EXPERIMENTAL

KLA578-1 for injection

Intervention Type: DRUG

Intravenous injection, single dose

Interventions

KLA578-1 for injection

Intravenous injection, single dose

Intervention Type: DRUG

Etopcoxib Tablets

P.O., single dose

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Health Volunteers (Age: 18~45 years);

2. Body Weight: Male≥50.0kg, Female≥45.0kg; 19.0 ≤BMI≤ 26.0;

3. There were no abnormalities in clinically significant physical examination, vital signs, 12-lead electrocardiogram, laboratory tests;

4. Heart rate ≥ 60 bpm and pulse ≥ 60 beats/min.

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 inducers or inhibitors of major CYP450 enzymes 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;

10. Tablet dysphagia;

11. Needle sickness, Hematosickness;

12. Massive blood loss (> 200 mL) in the past 3 months;

13. Female volunteers are pregnant or lactating;

14. History of unprotected sex within 2 weeks;

15. Special requirements for diet;

16. Heavy smoker ( more than 3 cigarettes/day) within 3 months;

17. History of alcohol abuse,or heavy alcohol intake (more than 14 units a week) within 6 months;

18. Heavy caffeine intake;

19. History of grapefruit, xanthine-rich foods intake within 7 days;

20. Positive alcohol test;

21. Positive drugs of abuse test result.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sichuan Kelun Pharmaceutical Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Wei Qi

Role: CONTACT

qiw@kelun.com

028-82339360

Facility Contacts

Guoping Yang

Role: primary

ygp9880@163.com

13974817168

Chengxian Guo

Role: backup

gchxyy@163.com

15580992599

Other Identifiers

KLA578-1-101

Identifier Type: -

Identifier Source: org_study_id