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
This trial accepts healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
KP405
DrugExperimental drug
Placebo
DrugPlacebo
Treatment groups
88 Participants
are divided into 11 treatment groups11
Treatment groupsSee each treatment group below.
Group A: Cohort 1Experimental treatment 2 interventions
Group B: Cohort 2Experimental treatment 2 interventions
Group C: Cohort 3Experimental treatment 2 interventions
Group D: Cohort 4Experimental treatment 2 interventions
Group E: Cohort 5Experimental treatment 2 interventions
Group F: Cohort 6Experimental treatment 2 interventions
Group G: Cohort 7Experimental treatment 2 interventions
Group H: Cohort 8Experimental treatment 2 interventions
Group I: Cohort 9Experimental treatment 2 interventions
Group J: Cohort 10Experimental treatment 2 interventions
Group K: Cohort 11Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Adverse event (AE) reporting
Clinical safety data from adverse event (AE) reporting
Time frame
Through study completion, an average of 1 year2
12-lead electrocardiogram (ECG)
Clinical safety data from 12-lead electrocardiogram (ECG) machine will automatically calculate: RR interval PR interval QRS complex QT interval QTcF (QT interval corrected for heart rate using Fridericia's formula) Heart rate (beats per minute)
Time frame
Through study completion, an average of 1 year3
Continous ECG monitoring
Clinical safety data from cardiac Holter monitoring
Time frame
Through study completion, an average of 1 year4
Blood pressure
Clinical safety data from supine blood pressure (mmHg)
Time frame
Through study completion, an average of 1 yearSecondary outcomes
1
Pharmacokinetics parameters - Cmax
Plasma PK concentrations including but not limited to: maximum plasma concentration (Cmax) (ng/ml)
Time frame
0-48 hours2
Pharmacokinetics parameters - tmax
Plasma PK concentrations including but not limited to: time to reach Cmax (tmax) (minutes)
Time frame
0-48 hours3
Pharmacokinetics parameters - AUC0-t
Plasma PK concentrations including but not limited to: area under the plasma concentration-time curve (AUC) from zero to the last quantifiable concentration () (ng/ml x hours)
Time frame
0-48 hours4
Pharmacokinetics parameters - AUC0-∞
Plasma PK concentrations including but not limited to: AUC from zero to infinity (AUC0-∞)(ng/ml x hours)
Time frame
0-48 hoursSponsors and contacts
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Source ClinicalTrials.gov