Phase I Study to Evaluate KP405 in Healthy and Parkinson's Disease Patients
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorKariya Pharmaceuticals
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- KP405
- Placebo
Treatment groups
88 Participants
are divided into 11 treatment groups11
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov