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

Recruiting now · Phase 1

Conditions studied: Healthy Volunteers

In brief

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

Key facts

Study ID

NCT07143318

Run by

Hunan Kelun Pharmaceutical Co., Ltd.

People needed

48

Starts

2025-06-05

Expected to finish

2026-05-31

Last updated by the study team

2026-05-26

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• The Third Xiangya Hospital of Central South University — Changsha, Hunan, China (enrolling)

Full record on ClinicalTrials.gov

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