Test new antibody slows progression
- Trial ID
- NCT06809400
- Official Title
- A Single- and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY4006896 in Healthy Participants and Participants With Parkinson's Disease
- Goal
- Test new antibody slows progression
- Phase
- PHASE1
- Status
- RECRUITING
- Sponsor
- Eli Lilly and Company
- Study Type
- INTERVENTIONAL
- Enrollment
- 127 participants
- Conditions
- Parkinson Disease
- Interventions
- LY4006896, Placebo
Plain-Language Summary
The goal is to test whether LY4006896 is safe, well tolerated, and how it behaves in the body while looking for early signs that it affects Parkinson's-related biology. LY4006896 is a humanized monoclonal antibody given by IV, designed to engage the transferrin receptor to help it get into the brain, and the trial will measure how it distributes, how long it lasts, and how it affects biomarkers while people stay on their usual Parkinson's meds. Part A enrolls healthy adults age 30 to 85 for single ascending doses; Part B enrolls people with Parkinson's age 40 to 85 who meet UK Brain Bank criteria, have a MoCA score of at least 24, and either are on a stable dopaminergic regimen for 90 days or are untreated but not expected to need treatment changes for a year. People with serious immune problems, significant anemia, uncontrolled blood pressure, or known allergies to monoclonal or transferrin receptor antibodies are excluded.
Locations
- Collaborative Neuroscience Network - CNS, Los Alamitos, California, United States
- Collaborative Neuroscience Network - CNS, Los Alamitos, California, United States
- K2 Medical Research, LLC, Maitland, Florida, United States
- Aqualane Clinical Research, Naples, Florida, United States
- Charter Research, Orlando, Florida, United States
- Progressive Medical Research, Port Orange, Florida, United States
- K2 Medical Research, LLC, The Villages, Florida, United States
- Charter Research, The Villages, Florida, United States
- QUEST Research Institute, Farmington Hills, Michigan, United States
- PPD Development, LP, Austin, Texas, United States
- Evergreen Health Research, Kirkland, Washington, United States
- Inland Northwest Research, Spokane, Washington, United States
- P-One Clinic, Hachiōji, Japan
- Oita University Hospital, Yufu, Japan
Frequently Asked Questions
- What is this trial testing?
- This trial is studying LY4006896. The goal is to test whether LY4006896 is safe, well tolerated, and how it behaves in the body while looking for early signs that it affects Parkinson's-related biology. LY4006896 is a humanized monoclonal antibody given by IV, designed to engage the transferrin receptor to help it get into the brain, and the trial will measure how it distributes, how long it lasts, and how it affects biomarkers while people stay on their usual Parkinson's meds. Part A enrolls healthy adults age 30 to 85 for single ascending doses; Part B enrolls people with Parkinson's age 40 to 85 who meet UK Brain Bank criteria, have a MoCA score of at least 24, and either are on a stable dopaminergic regimen for 90 days or are untreated but not expected to need treatment changes for a year. People with serious immune problems, significant anemia, uncontrolled blood pressure, or known allergies to monoclonal or transferrin receptor antibodies are excluded.
- Who can participate?
- Participants must be between 30 Years and 85 Years.
- Where is this trial located?
- This trial is recruiting at 14 locations.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This Phase 1 trial is estimated to last approximately 2 years and 10 months.