Overview
Phase I Study to Evaluate KP405 in Healthy and Parkinson's Disease Patients
Status:
Not yet recruiting
Not yet recruiting
Trial end date:
2026-03-31
2026-03-31
Target enrollment:
0
0
Participant gender:
All
All
Summary
This study will explore the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of KP405 as a potential new treatment for Parkinson's disease.Phase:
Early Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Kariya Pharmaceuticals
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 years of Screening or
head trauma with loss of consciousness within 6 months of Screening.