RECRUITINGEarly Phase 1INTERVENTIONAL
Phase I Study to Evaluate KP405 in Healthy and Parkinson's Disease Patients
A Phase I, Randomised, Double-Blinded, Placebo-Controlled Study to Evaluate KP405. Part 1: Single Ascending Dosing in Healthy Participants. Part 2: Multiple Ascending Dosing in Healthy Participants and Parkinson's Disease Patients.
About This Trial
This study will explore the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of KP405 as a potential new treatment for Parkinson's disease.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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.
Who Should NOT Join This Trial:
- 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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
DRUG
KP405
Experimental drug
DRUG
Placebo
Placebo
Locations (1)
MAC
Manchester, United Kingdom