Evaluating LY4006896 in Healthy Individuals and Those with Parkinson's Disease
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
This study is testing a new drug called LY4006896 to see if it's safe and how it works in both healthy people and those with Parkinson's disease.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 127 (estimated) |
| Ages | 30 Years to 85 Years |
| Sex | All |
| Sponsor | Eli Lilly and Company Industry-sponsored |
| Locations | 14 sites (Los Alamitos, California and 13 other locations) |
| Trial ID | NCT06809400 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the safety, tolerability, and pharmacokinetics/pharmacodynamics of the intravenous drug LY4006896 compared to a placebo in both healthy participants and individuals diagnosed with Parkinson's disease. Participants with Parkinson's will undergo a screening period of up to 120 days and receive four doses, while healthy participants will have a shorter screening of up to 35 days and receive one dose. The overall treatment and follow-up duration will last up to 61 weeks for those with Parkinson's and 48 weeks for healthy participants, culminating in a total study duration of up to 78 weeks for Parkinson's patients and 53 weeks for healthy participants.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with Parkinson's disease and healthy participants who meet specific eligibility criteria.
Not a fit: Patients with severe comorbidities or those not meeting the eligibility criteria for either healthy participants or Parkinson's disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into a new treatment option for Parkinson's disease, potentially improving patient outcomes.
How similar studies have performed: Other studies have explored similar pharmacological approaches, but the specific drug LY4006896 is being evaluated in this novel context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Part A Single Ascending Dose (SAD) and B Multiple Ascending Dose (MAD) * Have a body mass index within the range of 18 to 34 kilogram/square meter (kg/m²) (inclusive). * For Japanese participants: To qualify as a participant of first-generation Japanese origin, the participant, the participant's biological parents, and all of the participant's biological grandparents must be of exclusive Japanese descent and born in Japan. * Have venous access sufficient to allow for blood sampling or administration of study intervention for IV administration, or both. Part A (SAD) Only * Participant must be 30 to 85 years of age (inclusive), at the time of signing the informed consent * Are overtly healthy * For Chinese participants: To qualify as Chinese for this study, all 4 of the participant's biological grandparents must be exclusive Chinese descent and born in China. Part B (MAD) Only * Participant must be 40 to 85 years of age (inclusive), at the time of signing the informed consent * Diagnosis of Parkinson's disease per United Kingdom (UK) Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria. * If presently untreated for Parkinson's disease, clinical status is not expected to require changes in symptomatic treatment within 52 weeks from baseline. * If presently being treated for Parkinson's disease, receiving a stable dose of symptomatic dopaminergic therapy, including monoamine oxidase-B inhibitor, levodopa/carbidopa or dopamine agonist for at least 90 days prior to baseline and not expected to change within 52 weeks. * Have a Montreal Cognitive Assessment (MoCA) score of greater than or equal to (≥) 24. Exclusion Criteria: Part A (SAD) and B (MAD) * Have significant neurological disease affecting the central nervous system (CNS) (other than Parkinson's disease in Part B cohorts) that may affect the participant's ability to complete the study. * Have a history or presence of serious or unstable illnesses or conditions that, in the investigator's opinion, could interfere with the analyses in this study, or increase risk for study intervention administration, or result in a participant's life expectancy of less than 24 months. * Have known allergies to LY4006896, related compounds, or any components of the formulation, or history of allergic reactions to any transferrin receptor antibodies. * Have significant allergies to humanize monoclonal antibodies. * Have clinically significant multiple or severe drug allergies (including, but not limited to, erythema multiforme major, linear immunoglobulin A dermatosis, toxic epidermal necrolysis, or exfoliative dermatitis); or intolerance to topical corticosteroids, or severe posttreatment hypersensitivity reactions. * Have history or presence of uncontrolled asthma, significant autoimmune disease, hereditary angioedema, or known history of common variable immune deficiency. * Evidence of clinically significant anemia. Part A (SAD) Only * Have an abnormal blood pressure or pulse rate, or both, as determined by the investigator, or a preexisting history of hypertension. Part B (MAD) Only * Have an abnormal blood pressure or pulse rate, or both, as determined by the investigator, or have uncontrolled hypertension, defined as a systolic blood pressure \>150 mm Hg or a diastolic blood pressure \>95 mm Hg at Screening or Treatment Visits. * Have an implanted deep brain stimulation (DBS) system or any other implanted neurostimulation device (including but not limited to spinal cord stimulation, vagus nerve stimulation or investigational neuromodulation devices) * Are receiving continuous infusion therapy with anti-parkinsonian medications, including but not limited to subcutaneous foslevodopa-foscarbidopa, subcutaneous apomorphine, or intraduodenal/intestinal levodopa formulations
Where this trial is running
Los Alamitos, California and 13 other locations
- Collaborative Neuroscience Network - CNS — Los Alamitos, California, United States (Recruiting)
- Collaborative Neuroscience Network - CNS — Los Alamitos, California, United States (Recruiting)
- K2 Medical Research, LLC — Maitland, Florida, United States (Completed)
- Aqualane Clinical Research — Naples, Florida, United States (Recruiting)
- Charter Research — Orlando, Florida, United States (Recruiting)
- Progressive Medical Research — Port Orange, Florida, United States (Recruiting)
- K2 Medical Research, LLC — The Villages, Florida, United States (Recruiting)
- Charter Research — The Villages, Florida, United States (Recruiting)
- QUEST Research Institute — Farmington Hills, Michigan, United States (Recruiting)
- PPD Development, LP — Austin, Texas, United States (Recruiting)
- Evergreen Health Research — Kirkland, Washington, United States (Not_yet_recruiting)
- Inland Northwest Research — Spokane, Washington, United States (Not_yet_recruiting)
- P-One Clinic — Hachiōji, Japan (Recruiting)
- Oita University Hospital — Yufu, Japan (Recruiting)
Study contacts
- Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
- Email: LillyTrials@Lilly.com
- Phone: 1-317-615-4559
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.