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.
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY
This study will explore the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of KP405 as a potential new treatment for Parkinson's disease.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: t
View:
• 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.
Locations
Other Locations
United Kingdom
MAC
RECRUITING
Manchester
Contact Information
Primary
Ian Laquian, MBA
Ian.laquian@kariyapharma.com
5170029
Time Frame
Start Date: 2024-08-01
Estimated Completion Date: 2026-03-31
Participants
Target number of participants: 88
Treatments
Experimental: Cohort 1
KP405\_dose 1, single dose
Experimental: Cohort 2
KP405\_dose 2, single dose
Experimental: Cohort 3
KP405\_dose 3, single dose
Experimental: Cohort 4
KP405\_dose 4, single dose
Experimental: Cohort 5
KP405\_dose 5, single dose
Experimental: Cohort 6
KP405\_dose 6, single dose
Experimental: Cohort 7
KP405\_dose 1, multiple dose
Experimental: Cohort 8
KP405\_dose 2, multiple dose
Experimental: Cohort 9
KP405\_dose 3, multiple dose
Experimental: Cohort 10
KP405\_dose 4, multiple dose
Experimental: Cohort 11
KP405\_dose 5, multiple dose
Related Therapeutic Areas
Sponsors
Leads: Kariya Pharmaceuticals