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

Launched by KARIYA PHARMACEUTICALS · Dec 19, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called KP405 to see if it is safe for people with Parkinson's disease and healthy volunteers. The main goals of the study are to check how well the body absorbs and processes this medication. Researchers are currently looking for participants aged 65 to 74, as well as younger individuals from 29 to 219 years old, regardless of gender. To join the trial, participants must be healthy according to a doctor’s assessment or have a clinical diagnosis of Parkinson’s disease based on specific criteria.

If you decide to participate, you will undergo a thorough medical evaluation to ensure you're eligible. This includes a physical exam and tests to check your overall health. Throughout the trial, you will be monitored closely for any safety concerns and how well you tolerate the treatment. This study is an early-phase trial, which means it’s in the initial stages of testing to gather important information about the medication. Your involvement could help researchers learn more about potential new treatments for Parkinson's disease.

Gender

ALL

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.