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

CompletedEARLY_Phase 1

Sponsor: Kariya Pharmaceuticals

Conditions: Safety Issues, Tolerance

Interventions: KP405, Placebo

Countries: United Kingdom

This study will explore the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of KP405 as a potential new treatment for Parkinson's disease.

Eligibility overview

Sex: ALL

Age: 18 Years to 80 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

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.

Locations (1)

Manchester, United Kingdom