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Recruiting Phase 1 NCT07240675

Single-dose,First-in-human of KLA478

Trial Parameters

Condition Healthy Volunteers
Sponsor Hunan Kelun Pharmaceutical Co., Ltd.
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 40
Sex ALL
Min Age 18 Years
Max Age 45 Years
Start Date 2025-11-26
Completion 2026-09-30
Interventions
pramipexole hydrochloride sustained-release tabletsKLA478placebo

Brief Summary

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

Eligibility Criteria

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 mmH

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