KP405 for Parkinson's (NCT06189170)
Test safety of new medication
- Trial ID
- NCT06189170
- Official 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.
- Goal
- Test safety of new medication
- Phase
- EARLY_PHASE1
- Status
- RECRUITING
- Sponsor
- Kariya Pharmaceuticals
- Study Type
- INTERVENTIONAL
- Enrollment
- 88 participants
- Conditions
- Safety Issues, Tolerance
- Interventions
- KP405, Placebo
Summary For Families
The goal is to evaluate the safety and to learn how a new medication for Parkinson's is processed by the body and affects the body, as an early step toward seeing if it could help people with the disease. The study gives single increasing doses to healthy volunteers in the first part, then repeated increasing doses to healthy volunteers and people with Parkinson's in the second part, with participants randomly assigned to the new medication or a placebo and neither participants nor staff told which one they receive while researchers measure absorption, clearance, and effects. Adults 18 to 80 may join; healthy volunteers must pass a medical evaluation including heart monitoring and lab tests, people with Parkinson's must meet United Kingdom Brain Bank diagnostic criteria, and those with other major health problems, recent stroke, memory problems, recent seizures, or recent head injury are excluded.
Locations
- MAC, Manchester, United Kingdom
Frequently Asked Questions
- What is this trial testing?
- This trial is studying KP405. The goal is to evaluate the safety and to learn how a new medication for Parkinson's is processed by the body and affects the body, as an early step toward seeing if it could help people with the disease. The study gives single increasing doses to healthy volunteers in the first part, then repeated increasing doses to healthy volunteers and people with Parkinson's in the second part, with participants randomly assigned to the new medication or a placebo and neither participants nor staff told which one they receive while researchers measure absorption, clearance, and effects. Adults 18 to 80 may join; healthy volunteers must pass a medical evaluation including heart monitoring and lab tests, people with Parkinson's must meet United Kingdom Brain Bank diagnostic criteria, and those with other major health problems, recent stroke, memory problems, recent seizures, or recent head injury are excluded.
- Who can participate?
- Participants must be between 18 Years and 80 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This Phase 1 trial is estimated to last approximately 1 year and 5 months.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.