RecruitingPhase 1NCT07143318

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

A Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses of KLA578-1 for Injection in Healthy Volunteers

Sponsor

Hunan Kelun Pharmaceutical Co., Ltd.

Enrollment

48 participants

Start Date

Jun 5, 2025

Study Type

INTERVENTIONAL

Conditions

Healthy Volunteers

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

Eligibility

Min Age: 18 YearsMax Age: 45 Years

Inclusion Criteria4

Health Volunteers (Age: 18~45 years);
Body Weight: Male≥50.0kg, Female≥45.0kg; 19.0 ≤BMI≤ 26.0;
There were no abnormalities in clinically significant physical examination, vital signs, 12-lead electrocardiogram, laboratory tests;
Heart rate ≥ 60 bpm and pulse ≥ 60 beats/min.

Exclusion Criteria21

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 inducers or inhibitors of major CYP450 enzymes within 30 days;
History of any clinical study within 3 months;
History of any vaccine within 1 month;
History of any drug abuse;
Tablet dysphagia;
Needle sickness, Hematosickness;
Massive blood loss (> 200 mL) in the past 3 months;
Female volunteers are pregnant or lactating;
History of unprotected sex within 2 weeks;
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;
Heavy caffeine intake;
History of grapefruit, xanthine-rich foods intake within 7 days;
Positive alcohol test;
Positive drugs of abuse test result.

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Interventions

DRUGKLA578-1 for injection

Intravenous injection, single dose

DRUGEtopcoxib Tablets

P.O., single dose

Locations(1)

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

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NCT07143318

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