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Recruiting EARLY_Phase 1 NCT06189170

Phase I Study to Evaluate KP405 in Healthy and Parkinson's Disease Patients

Trial Parameters

Condition Safety Issues
Sponsor Kariya Pharmaceuticals
Study Type INTERVENTIONAL
Phase EARLY_Phase 1
Enrollment 88
Sex ALL
Min Age 18 Years
Max Age 80 Years
Start Date 2024-08-01
Completion 2025-12-31
Interventions
KP405Placebo

Brief Summary

This study will explore the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of KP405 as a potential new treatment for Parkinson's disease.

Eligibility Criteria

Inclusion Criteria: * Healthy as determined by a responsible physician, based on medical evaluation including medical history, physical examination, concomitant medication, vital signs, 12-lead ECG, cardiac Holter monitoring and clinical laboratory evaluations. * Clinical diagnosis of Parkinson's disease meeting United Kingdom Brain Bank criteria. Exclusion Criteria: * Clinically relevant history of abnormal physical or mental health interfering with the study as determined by medical history and physical examinations obtained during Screening as judged by the Investigator (including \[but not limited to\], neurological, psychiatric, endocrine, cardiovascular, respiratory, gastrointestinal, hepatic, or renal disorder), excluding Parkinson's disease. * Clinically significant, as judged by the Investigator, neurologic disorder (other than Parkinson's disease) including history of stroke or transient ischaemic attack within 12 months of Screening, cognitive impairment, seizure within 5 ye

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