A Clinical Trial of LY3962681 in Healthy Volunteers and in Patients With Parkinson's Disease
Start Date
8/27/2024
Completion Date
7/23/2030
Summary
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics/pharmacodynamics (PK/PD) of LY3962681 in healthy volunteers and patients with Parkinson's disease. The study consists of two parts, the Single Ascending Dose (SAD) study and the Multiple Ascending Dose (MAD) study. During the SAD portion of the study, healthy volunteers will receive a single dose of LY3962681 or placebo (artificial cerebrospinal fluid \[aCSF\]) administered intrathecally (into the spinal fluid). During the MAD portion of the study, patients with Parkinson's disease will receive two doses of either LY3962681 or placebo (aCSF) administered intrathecally (into the spinal fluid), 12 to 24 weeks apart. * The treatment period in the SAD study will be 1 day. The treatment period in the MAD study will be 2 dosing days, 12 to 24 weeks apart. * The follow-up period in the SAD study will be up to 52 weeks. The follow-up period in the MAD study will be up to 52 weeks after Dose 2.
Eligibility Criteria
Age Range: 30 years to 80 years
Interventions
LY3962681
Placebo (aCSF)
Conditions
Locations
CenExel
Englewood, Colorado 80113
United States
XingImaging LLC
New Haven, Connecticut 06510
United States
Aqualane Clinical Research
Naples, Florida 34105
United States
Northwestern University Feinberg School of Medicine Dept of Neurology
Chicago, Illinois 60611
United States
Quest Research Institute - Alcanza
Farmington Hills, Michigan 48334
United States
University of Pennsylvania, Dept of Neurology
Philadelphia, Pennsylvania 19107
United States
Austin Clinic PPD
Austin, Texas 78744-1625
United States
Universitätsklinikum Düsseldorf
Düsseldorf, North Rhine-Westphalia 40225
Germany
Universitätsklinikum Münster
Münster, North Rhine-Westphalia 48149
Germany
Ehime University Hospital
Tōon, Ehime 791-0295
Japan
Oita University Hospital
Yufu, Oita Prefecture 879-5593
Japan
P-One Clinic, Keikokai Medical Corporation
Hachiōji, Tokyo 192-0071
Japan
Radboud Universitair Medisch Centrum
Nijmegen, Gelderland 6525 GA
Netherlands
CTC Netherlands BV
Groningen, Provincie Groningen 9713 GZ
Netherlands
Southampton General Hospital, NHS Trust
Southampton, Hampshire SO16 6TH
United Kingdom
John Radcliffe Hospital
Oxford, Oxfordshire OX3 9DU
United Kingdom