Ireland
--:--IST
Recruiting Phase 1

Single-dose,First-in-human of KLA478

NCT07240675 · tracked via the Priya Life Science China tracker
Phase
Phase 1
Started
2025-11-26
Last updated
2026-05-26

Condition(s) studied

Healthy Volunteers

Investigational drug(s) / intervention(s)

pramipexole hydrochloride sustained-release tabletsKLA478placebo

pramipexole hydrochloride sustained-release tablets: P.O., single dose

KLA478: intramuscular injection, single dose

placebo: intramuscular injection, single dose

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
45 Years
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • Incidence and severity of adverse events (AEs) — Up to Day 109

Trial sites (1)

FacilityCityRegionStatus
Huashan Hospital Affiliated to Fudan University Shanghai Shanghai Municipality Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07240675 on ClinicalTrials.gov ↗ ← All trials in China