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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
124
IT injection
IT injection
CenExel
Englewood, Colorado, United States
NOT_YET_RECRUITINGXingImaging LLC
New Haven, Connecticut, United States
NOT_YET_RECRUITINGAqualane Clinical Research
Naples, Florida, United States
RECRUITINGNorthwestern University Feinberg School of Medicine Dept of Neurology
Chicago, Illinois, United States
NOT_YET_RECRUITINGQuest Research Institute - Alcanza
Farmington Hills, Michigan, United States
NOT_YET_RECRUITINGUniversity of Pennsylvania, Dept of Neurology
Philadelphia, Pennsylvania, United States
NOT_YET_RECRUITINGAustin Clinic PPD
Austin, Texas, United States
COMPLETEDUniversitätsklinikum Düsseldorf
Düsseldorf, North Rhine-Westphalia, Germany
NOT_YET_RECRUITINGUniversitätsklinikum Münster
Münster, North Rhine-Westphalia, Germany
NOT_YET_RECRUITINGEhime University Hospital
Tōon, Ehime, Japan
RECRUITING...and 6 more locations
Incidence of Serious Adverse Events (SAEs)
Time frame: Up to 76 weeks
Incidence of Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to 76 weeks
Number of discontinuations due to Adverse Events (AEs)
Time frame: Up to 76 weeks
LY3962681 Maximum Observed Concentration (Cmax)
Time frame: Up to 76 weeks
LY3962681 area under the concentration versus time curve (AUC)
Time frame: Up to 76 weeks
Change from baseline in CSF total alpha-synuclein
Time frame: Up to 76 weeks
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