Status:
RECRUITING
First-in-Human Single and Multiple Dose of KLA578-1 for Injection
Lead Sponsor:
Sichuan Kelun Pharmaceutical Co., Ltd
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
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 volunt...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 5 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2026
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT07143318
Start Date
June 5 2025
End Date
May 31 2026
Last Update
August 27 2025
Active Locations (1)
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1
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China, 611130