KP405CS01
Research type
Research Study
Full title
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.
IRAS ID
1007990
Contact name
Mikael Thomsen
Contact email
Sponsor organisation
Kariya Pharmaceuticals ApS
Eudract number
2023-000484-32
Research summary
The purpose of this study is to test a drug KP405 (the ‘study drug’) developed by Kariya Pharmaceuticals for the treatment of Parkinson’s disease. This study aims to assess the safety and tolerability of the study drug, to see how the body absorbs and removes the study drug, and to assess the effect of the study drug on the body. Parkinson’s disease is a condition in which cells that produce a chemical called dopamine in parts of the brain stop working properly, leading to damage of those parts of the brain progressively over many years. Dopamine plays a vital role in the body as it allows messages to be sent to the parts of the brain that coordinate movement. Symptoms of Parkinson’s disease appear when the brain can’t make enough dopamine to control movement properly. There are three main symptoms – involuntary shaking of particular parts of the body (tremor), slowness of movement, and rigidity (muscle stiffness). There is currently no cure for Parkinson’s disease, but treatments are available to help control the main symptoms and maintain quality of life for as long as possible. The study drug is being developed in the hope of providing a new treatment for Parkinson’s disease by protecting the dopamine-producing cells from becoming damaged, so that they can continue to produce dopamine and slow down/stop the progression of the disease. This study consists of 2 parts. Part 1 of will be the first time that the study drug will be given to humans; it will be given as a single dose on one day. Part 2 will be the first time that the study drug will be given to humans over multiple dosing days; it will be given once daily for 7 consecutive days. Participants will include healthy male volunteers, healthy elderly male and female volunteers and male and female Parkinson's disease patients. All participants will be randomised to receive study drug or placebo. Participants will be in the study for approximately 6 weeks
REC name
Wales REC 2
REC reference
23/WA/0149
Date of REC Opinion
30 Oct 2023
REC opinion
Further Information Favourable Opinion