Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| J5V-MC-ORAA | Other Identifier | Eli Lilly and Company |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to generate evidence of the safety, tolerability, and pharmacokinetics/pharmacodynamics of IV LY4006896 compared with placebo in healthy participants and participants with Parkinson's disease.
The screening period will be up to 120 days for participants with Parkinson's disease who receive 4 doses, and up to 35 days for healthy participants who receive 1 dose. The treatment and follow-up duration will be up to 61 weeks for participants with Parkinson's disease, and 48 weeks for healthy participants. The total study duration will be up to 78 weeks for participants with Parkinson's disease, and 53 weeks for healthy participants.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A LY4006896 + Placebo | Experimental | Healthy participants will receive a single escalating dose of LY4006896 and matching placebo. |
|
| Part B LY4006896 + Placebo | Experimental | Participants with Parkinson's disease will receive multiple escalating doses of LY4006896 and matching placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY4006896 | Drug | Administered intravenously (IV) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with One or More Serious Adverse Event(s) (SAEs) Part A | Baseline to Week 48 | |
| Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs) Part A | Baseline to Week 48 | |
| Number of Participants with One or More SAEs Part B | Baseline to Week 61 | |
| Number of Participants with One or More TEAEs Part B | Baseline to Week 61 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4006896 ARC-Associated Antisense Part A | Baseline to Week 48 | |
| PK: Cmax of LY4006896 ARC-Associated Antisense Part B | Baseline to Week 61 | |
Not provided
Inclusion Criteria:
Part A Single Ascending Dose (SAD) and B Multiple Ascending Dose (MAD)
Part A (SAD) Only
Part B (MAD) Only
Exclusion Criteria:
Part A (SAD) and B (MAD)
Part A (SAD) Only
Part B (MAD) Only
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Collaborative Neuroscience Network - CNS | Recruiting | Los Alamitos | California | 90720 | United States |
Not provided
| Label | URL |
|---|---|
| A Study of LY4006896 in Healthy Participants and Participants With Parkinson's Disease | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a single-blind study where the participants, investigator, and site personnel (except pharmacy staff) are blinded to study intervention.
| Placebo |
| Drug |
Administered IV |
|
| PK: Area Under the Concentration versus Time Curve (AUC) of LY4006896 ARC-Associated Antisense Part A |
| Baseline to Week 48 |
| PK: AUC of LY4006896 ARC-Associated Antisense Part B | Baseline to Week 61 |
| Effect of LY4006896 on Aggregation-Competent Alpha-Synuclein in Skin Part B | Alpha-synuclein seed amplification positivity | Baseline to Week 61 |
| Effect of LY4006896 on Aggregation-Competent Alpha-Synuclein in Cerebrospinal Fluid (CSF) Part B | Alpha-synuclein seed amplification positivity | Baseline to Week 61 |
| Collaborative Neuroscience Network - CNS | Recruiting | Los Alamitos | California | 90720 | United States |
|
| K2 Medical Research, LLC | Completed | Maitland | Florida | 32751 | United States |
| Aqualane Clinical Research | Recruiting | Naples | Florida | 34105 | United States |
|
| Charter Research | Recruiting | Orlando | Florida | 32803 | United States |
|
| Progressive Medical Research | Recruiting | Port Orange | Florida | 32127 | United States |
|
| K2 Medical Research, LLC | Recruiting | The Villages | Florida | 32159 | United States |
|
| Charter Research | Recruiting | The Villages | Florida | 32162-2698 | United States |
|
| QUEST Research Institute | Recruiting | Farmington Hills | Michigan | 48334 | United States |
|
| PPD Development, LP | Recruiting | Austin | Texas | 78744 | United States |
|
| Evergreen Health Research | Not yet recruiting | Kirkland | Washington | 98034 | United States |
|
| Inland Northwest Research | Not yet recruiting | Spokane | Washington | 99202 | United States |
|
| P-One Clinic | Recruiting | HachiĆji | 192-0071 | Japan |
|
| Oita University Hospital | Recruiting | Yufu | 879-5593 | Japan |
|
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
Not provided
Not provided