A Randomized, Double-blind, Placebo-controlled, Single-ascending-dose Study in Healthy Volunteers and a Double-blind, Placebo-controlled, Multiple-ascending-dose Study in Patients With Parkinson's Disease to Evaluate the Safety, Tolerability, and PK/PD of LY3962681
- Conditions
- Parkinson's Disease
- Registration Number
- NCT06565195
- Lead Sponsor
- Prevail Therapeutics
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 108
Inclusion Criteria:<br><br> - Participant is overtly healthy as determined by medical evaluation. Rescreening is<br> allowed in this study.<br><br> - A Montreal Cognitive Assessment score greater than 26.<br><br> - Stable use of background medications at least 8 weeks prior to IP administration,<br> including but not limited to those used for treatment of Parkinson's disease<br> (including deep brain stimulation), and the investigator must expect that<br> participant can tolerate a minimum of 6 months without dose adjustment.<br><br>MAD study only<br><br> - Participant has a diagnosis of Parkinson's disease per UK Parkinson's Disease<br> Society Brain Bank Clinical Diagnostic Criteria.<br><br> - Hoehn and Yahr Stage 1 to 2 in the practically defined OFF state.<br><br> - A positive result on CSF alpha-synuclein Seed Amplification Assay. (A prior positive<br> result [within 1 year of screening] accepted with sponsor approval if patient did<br> not participate in another Parkinson's disease clinical trial during this period.)<br> (US and Japan only)<br><br> - UPSIT score of 10 percentile or less, corrected for age and sex (EU and UK only).<br><br> - An abnormal DaT-SPECT consistent with parkinsonism. (History of an abnormal DaTSPECT<br> with the report confirmed by study investigator will be accepted.)<br><br> - For participants not taking Parkinson's disease medications, not expected to<br> initiate treatment within 6 months.<br><br> - Have a body weight within 40 kg (88 pounds) to 110 kg (242 pounds), inclusive, and<br> body mass index within the range of 17 to 34 kg/m^2, inclusive.<br><br>Exclusion Criteria:<br><br> - MAD study only: Significant neurological disease affecting the central nervous<br> system other than Parkinson's disease that may be a cause for the participant's<br> clinical symptoms or may confound study objectives.<br><br> - Current concomitant disease or serious or unstable illnesses, including central<br> nervous system (SAD study only), cardiovascular, hepatic, renal, gastroenterology,<br> respiratory, endocrinologic, neurologic (MAD study only: other than Parkinson's<br> disease), psychiatric, immunologic, or hematologic disease and other conditions<br> that, in the investigator's opinion, could interfere with the conduct of the study<br> or that would, in the opinion of the investigator, pose an unacceptable safety risk<br> to the participant.<br><br> - Participant is generally frail or has any medical disorders that, in the opinion of<br> the investigator, could interfere with study-related procedures (including safe<br> performance of IT injection or LP), such as prohibitive spinal diseases, bleeding<br> diathesis, clinically significant coagulopathy, thrombocytopenia, or increased<br> intracranial pressure.<br><br> - Have a 12-lead ECG abnormality at screening that, in the opinion of the<br> investigator, increases the risks associated with participating in the study or may<br> confound ECG data analysis.<br><br> - MAD study only: Treatment with continuous intestinal delivery Parkinson's disease<br> medication (for example, Duodopa).<br><br>Other protocol-defined inclusion/exclusion criteria may apply.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of Serious Adverse Events (SAEs);Incidence of Treatment Emergent Adverse Events (TEAEs);Number of discontinuations due to Adverse Events (AEs)
- Secondary Outcome Measures
Name Time Method LY3962681 Maximum Observed Concentration (Cmax);LY3962681 area under the concentration versus time curve;Change from baseline in CSF total alpha-synuclein