Actively Recruiting
First-in-Human Single and Multiple Dose of KLA578-1 for Injection
Led by Sichuan Kelun Pharmaceutical Co., Ltd · Updated on 2025-08-27
48
Participants Needed
1
Research Sites
51 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
First-in-Human Single and Multiple Dose of KLA578-1 for Injection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy volunteers aged 18 to 45 years
- Male volunteers weighing at least 50.0 kg, female volunteers weighing at least 45.0 kg
- Body mass index (BMI) between 19.0 and 26.0
- No abnormalities in physical examination, vital signs, electrocardiogram, and laboratory tests
- Heart rate and pulse rate of at least 60 beats per minute
You will not qualify if you...
- Allergy or drug hypersensitivity
- Significant medical history
- Gastrointestinal ulcers or bleeding
- Surgery within the past 4 weeks
- Medication use within the past 14 days
- Use of CYP450 enzyme inducers or inhibitors within the past 30 days
- Participation in any clinical study within the past 3 months
- Vaccination within the past 1 month
- History of drug abuse
- Difficulty swallowing tablets
- Needle or blood-related phobias
- Blood loss over 200 mL in the past 3 months
- Pregnancy or lactation for female volunteers
- Unprotected sexual activity within 2 weeks
- Special dietary requirements
- Heavy smoking (more than 3 cigarettes per day) within 3 months
- History of alcohol abuse or heavy drinking (more than 14 units per week) within 6 months
- High caffeine consumption
- Consumption of grapefruit or xanthine-rich foods within 7 days
- Positive alcohol or drug abuse test results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China, 611130
Actively Recruiting
Research Team
W
Wei Qi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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