--- title: Test new antibody slows progression nct_id: NCT06809400 phase: PHASE1 status: RECRUITING sponsor: Eli Lilly and Company study_type: INTERVENTIONAL canonical_url: "https://parkinsonspathways.com/trial/NCT06809400" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06809400" last_fetched: "2026-05-10T14:07:28.516Z" source: "Parkinson's Pathways (curated)" --- # Test new antibody slows progression **Goal (in five words):** Test new antibody slows progression **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 **Trial ID:** [NCT06809400](https://clinicaltrials.gov/study/NCT06809400) ## Key Facts - **Phase:** PHASE1 - **Status:** RECRUITING - **Study Type:** INTERVENTIONAL - **Sponsor:** Eli Lilly and Company - **Target Enrollment:** 127 participants - **Start Date:** 2025-02-18 - **Completion Date:** 2028-01 - **Conditions:** Parkinson Disease - **Interventions:** LY4006896, Placebo - **Intervention Types:** DRUG ## Summary For Families 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. ## Eligibility - **Minimum age:** 30 Years - **Maximum age:** 85 Years - **Sex:** ALL ### Full 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 ``` ## Locations (14) - Collaborative Neuroscience Network - CNS, Los Alamitos, California, United States _(33.8031, -118.0726)_ - (CONTACT) — 844-424-9494 - Steven Reynolds — (PRINCIPAL_INVESTIGATOR) - Collaborative Neuroscience Network - CNS, Los Alamitos, California, United States _(33.8031, -118.0726)_ - (CONTACT) — 562-742-7116 - Omid Omidvar — (PRINCIPAL_INVESTIGATOR) - K2 Medical Research, LLC, Maitland, Florida, United States _(28.6278, -81.3631)_ - Aqualane Clinical Research, Naples, Florida, United States _(26.1423, -81.7960)_ - (CONTACT) — 239-529-6780 - William Justiz — (PRINCIPAL_INVESTIGATOR) - Charter Research, Orlando, Florida, United States _(28.5383, -81.3792)_ - (CONTACT) — 407-337-1000 - Diana Balsalobre — (PRINCIPAL_INVESTIGATOR) - Progressive Medical Research, Port Orange, Florida, United States _(29.1383, -80.9956)_ - (CONTACT) — 386-304-7070 - Alexander White — (PRINCIPAL_INVESTIGATOR) - K2 Medical Research, LLC, The Villages, Florida, United States _(28.9341, -81.9599)_ - (CONTACT) — 321-278-5590 - Craig Curtis — (PRINCIPAL_INVESTIGATOR) - Charter Research, The Villages, Florida, United States _(28.9341, -81.9599)_ - (CONTACT) — 352-775-1000 - Jeffrey Norton — (PRINCIPAL_INVESTIGATOR) - QUEST Research Institute, Farmington Hills, Michigan, United States _(42.4853, -83.3772)_ - (CONTACT) — 248-957-8940 - Aaron Ellenbogen — (PRINCIPAL_INVESTIGATOR) - PPD Development, LP, Austin, Texas, United States _(30.2672, -97.7431)_ - (CONTACT) — 877-773-3707 - Sabrina Merchant — (PRINCIPAL_INVESTIGATOR) - Evergreen Health Research, Kirkland, Washington, United States _(47.6815, -122.2087)_ - (CONTACT) — 425-899-5385 - Pinky Agarwal — (PRINCIPAL_INVESTIGATOR) - Inland Northwest Research, Spokane, Washington, United States _(47.6597, -117.4291)_ - (CONTACT) — 509-960-2818 - Jason Aldred — (PRINCIPAL_INVESTIGATOR) - P-One Clinic, Hachiōji, Japan _(35.6558, 139.3239)_ - (CONTACT) — 81120023812 - Kenichi Furihata — (PRINCIPAL_INVESTIGATOR) - Oita University Hospital, Yufu, Japan _(33.1956, 131.3783)_ - (CONTACT) — 81120023812 - Naoto Uemura — (PRINCIPAL_INVESTIGATOR) ## Central Contacts - Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or — (CONTACT) — 1-317-615-4559 — LillyTrials@Lilly.com - Physicians interested in becoming principal investigators please contact — (CONTACT) — clinical_inquiry_hub@lilly.com --- *Canonical: https://parkinsonspathways.com/trial/NCT06809400* *HTML version: https://parkinsonspathways.com/trial/NCT06809400* *Source data: https://clinicaltrials.gov/study/NCT06809400*