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
Eli Lilly and Company
Summary
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.
Description
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.
Eligibility
- Age range
- 30–85 years
- Sex
- All
- Healthy volunteers
- Yes
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…
Interventions
- DrugLY4006896
Administered intravenously (IV)
- DrugPlacebo
Administered IV
Locations (14)
- Collaborative Neuroscience Network - CNSLos Alamitos, California
- Collaborative Neuroscience Network - CNSLos Alamitos, California
- K2 Medical Research, LLCMaitland, Florida
- Aqualane Clinical ResearchNaples, Florida
- Charter ResearchOrlando, Florida
- Progressive Medical ResearchPort Orange, Florida