AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

Single-dose,First-in-human of KLA478

RecruitingPhase 1Ages 18 Years - 45 YearsAllHunan Kelun Pharmaceutical Co., Ltd.
💬

In plain words

What the trial is, and whether it could suit you

The purpose of this study is to evaluate the safety and tolerability and pharmacokinetics of single doses of KLA478 in healthy volunteers;

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: 1. Sign the informed consent form 2. Health participants (Age: 18\~45 years); 3. Body Weight: Male≥50.0kg, Female≥45.0kg; 19 ≤BMI≤ 28.0kg/m2; 4. Clinical examination normal, or abnormal with no clinical significance; 5. Agreed to use contraception for 3-6 months. Exclusion Criteria: 1. Allergy or Drug hypersensitivity; 2. Clinically significant Medical History; 3. Subjects with difficult venous blood collection/intolerance to venipuncture, or with a history of needle phobia/blood phobia; 4. Assess injection site abnormalities; 5. History of drugs that may interact with pramipexole within 1 month; 6. History of any Medication within 2 weeks; 7. Massive blood loss (\> 200 mL) in the past 3 months; 8. History of any surgery within 3 months, or plan to undergo surgery during the trial; 9. History of any clinical study within 90 days; 10. History of any vaccine within 1 month,or Plan to get vaccinated during the trial period; 11. systolic blood pressure decreased ≥20 mmHg or diastolic blood pressure decreased ≥10 mmHg within 3 minutes from supine to upright position; 12. QTcF\>450 ms; 13. Abnormal vital signs with clinical significance ; 14. Serum potassium level exceeds the reference range.; 15. Pre-transfusion test abnormal; 16. Lactation or pregnancy test positive ; 17. History of any drug abuse or positive drugs of abuse test result; 18. Previous alcohol abuse or unwillingness to stop drinking or alcohol breath test positive; 19. more than 3 cigarettes per day in 3 months, or unwilling to stop during the trial; 20. Intake of special diets that affect drug absorption, distribution, metabolism and excretion within 48 hours; 21. Have special requirements for diet; 22. Unprotected sexual behavior within 2 weeks; 23. engaged in driving vehicles, operating machinery, high-altitude work or other potentially dangerous behavior; 24. Inappropriate for participation in this trial as judged by the investigator.
💊

What it tests

  • pramipexole hydrochloride sustained-release tablets
  • KLA478
  • placebo
📍

Where

1 site
Huashan Hospital Affiliated to Fudan University
Shanghai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy