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Completed
NCT06189170
Phase I Study to Evaluate KP405 in Healthy and Parkinson's Disease Patients
Conditions: Safety Issues, Tolerance
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: Yes
Phase: EARLY_PHASE1
Enrollment: 88
Sponsor: Kariya Pharmaceuticals
Location: MAC Manchester
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 years of Screening or head trauma with loss of consciousness within 6 months of Screening.
Source: ClinicalTrials.gov (NCT06189170). StuddyBuddy aggregates publicly available trial information.