Evaluating KP405 for safety in healthy individuals and those with Parkinson's disease
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.
This study is testing a new treatment called KP405 to see if it's safe for both healthy people and those with Parkinson's disease.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 88 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Kariya Pharmaceuticals Industry-sponsored |
| Locations | 1 site (Manchester) |
| Trial ID | NCT06189170 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the safety, pharmacokinetics, and pharmacodynamics of KP405, a potential new treatment for Parkinson's disease. It will involve both healthy participants and those diagnosed with Parkinson's disease according to established criteria. Participants will receive either KP405 or a placebo, and their responses will be closely monitored to gather data on the drug's effects and tolerability.
Who should consider this trial
Good fit: Ideal candidates include healthy individuals and patients diagnosed with Parkinson's disease who meet specific inclusion criteria.
Not a fit: Patients with significant neurological or psychiatric disorders other than Parkinson's disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a new treatment option that improves the management of Parkinson's disease.
How similar studies have performed: While this approach is exploring new treatment avenues, similar studies have shown promise in evaluating safety and efficacy in early-phase trials.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Where this trial is running
Manchester
- Mac — Manchester, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Ezanul A Wahab, MD — Mac
- Study coordinator: Ian Laquian, MBA
- Email: Ian.laquian@kariyapharma.com
- Phone: 5170029
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.