Actively Recruiting
Single-dose,First-in-human of KLA478
Led by Hunan Kelun Pharmaceutical Co., Ltd. · Updated on 2026-02-27
40
Participants Needed
1
Research Sites
44 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 doses of KLA478 in healthy volunteers；
CONDITIONS
Official Title
Single-dose,First-in-human of KLA478
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form
- Healthy adults aged 18 to 45 years
- Body weight: males at least 50.0 kg, females at least 45.0 kg
- Body mass index (BMI) between 19 and 28.0 kg/m2
- Normal clinical examination or abnormal findings with no clinical significance
- Agreed to use contraception for 3 to 6 months
You will not qualify if you...
- Allergy or drug hypersensitivity
- Clinically significant medical history
- Difficulty with venous blood collection or intolerance to venipuncture
- History of needle phobia or blood phobia
- Injection site abnormalities
- Use of drugs that might interact with pramipexole within 1 month
- Use of any medication within 2 weeks
- Massive blood loss (> 200 mL) in past 3 months
- Surgery within past 3 months or planned surgery during trial
- Participation in another clinical study within 90 days
- Vaccination within 1 month or planned vaccination during trial
- Significant drop in blood pressure within 3 minutes of standing
- QTcF interval greater than 450 ms
- Abnormal vital signs with clinical significance
- Serum potassium level outside normal range
- Abnormal pre-transfusion test
- Positive pregnancy or lactation test
- History of drug abuse or positive drug abuse test
- History of alcohol abuse or unwillingness to stop drinking
- Smoking more than 3 cigarettes per day in past 3 months or unwilling to stop
- Special diets affecting drug absorption within 48 hours
- Special dietary requirements
- Unprotected sexual behavior within 2 weeks
- Engaged in driving, operating machinery, or high-risk work
- Investigator judgment of unsuitability for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China, 201107
Actively Recruiting
Research Team
W
Wei Qi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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