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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
127
Collaborative Neuroscience Network - CNS
Los Alamitos, California, United States
NOT_YET_RECRUITINGCollaborative Neuroscience Network - CNS
Los Alamitos, California, United States
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Part A
Time frame: Baseline to Week 48
Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs) Part A
Time frame: Baseline to Week 48
Number of Participants with One or More SAEs Part B
Time frame: Baseline to Week 61
Number of Participants with One or More TEAEs Part B
Time frame: Baseline to Week 61
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4006896 ARC-Associated Antisense Part A
Time frame: Baseline to Week 48
PK: Cmax of LY4006896 ARC-Associated Antisense Part B
Time frame: Baseline to Week 61
PK: Area Under the Concentration versus Time Curve (AUC) of LY4006896 ARC-Associated Antisense Part A
Time frame: Baseline to Week 48
PK: AUC of LY4006896 ARC-Associated Antisense Part B
Time frame: Baseline to Week 61
Effect of LY4006896 on Aggregation-Competent Alpha-Synuclein in Skin Part B
Alpha-synuclein seed amplification positivity
Time frame: Baseline to Week 61
Effect of LY4006896 on Aggregation-Competent Alpha-Synuclein in Cerebrospinal Fluid (CSF) Part B
Alpha-synuclein seed amplification positivity
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
K2 Medical Research, LLC
Maitland, Florida, United States
NOT_YET_RECRUITINGAqualane Clinical Research
Naples, Florida, United States
NOT_YET_RECRUITINGCharter Research
Orlando, Florida, United States
NOT_YET_RECRUITINGProgressive Medical Research
Port Orange, Florida, United States
NOT_YET_RECRUITINGK2 Medical Research, LLC
The Villages, Florida, United States
NOT_YET_RECRUITINGCharter Research
The Villages, Florida, United States
NOT_YET_RECRUITINGQUEST Research Institute
Farmington Hills, Michigan, United States
NOT_YET_RECRUITINGPPD Development, LP
Austin, Texas, United States
RECRUITING...and 4 more locations
Time frame: Baseline to Week 61