Status:
RECRUITING
Phase I Study to Evaluate KP405 in Healthy and Parkinson's Disease Patients
Lead Sponsor:
Kariya Pharmaceuticals
Conditions:
Safety Issues
Tolerance
Eligibility:
All Genders
18-80 years
Phase:
EARLY_PHASE1
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
- 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
- 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 years of Screening or head trauma with loss of consciousness within 6 months of Screening.
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2026
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT06189170
Start Date
August 1 2024
End Date
March 31 2026
Last Update
March 7 2025
Active Locations (1)
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1
MAC
Manchester, United Kingdom