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

Status: Recruiting
Location: See all (13) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 30
Maximum Age: 85
Healthy Volunteers: t
View:

⁃ 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

• Participant must be 30 to 85 years of age (inclusive), at the time of signing the informed consent

• Are overtly healthy

• For Chinese participants: To qualify as Chinese for this study, all 4 of the participant's biological grandparents must be exclusive Chinese descent and born in China.

⁃ Part B (MAD) Only

• Participant must be 40 to 85 years of age (inclusive), at the time of signing the informed consent

• Diagnosis of Parkinson's disease per United Kingdom (UK) Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria.

• If presently untreated for Parkinson's disease, clinical status is not expected to require changes in symptomatic treatment within 52 weeks from baseline.

• If presently being treated for Parkinson's disease, receiving a stable dose of symptomatic dopaminergic therapy, including monoamine oxidase-B inhibitor, levodopa/carbidopa or dopamine agonist for at least 90 days prior to baseline and not expected to change within 52 weeks.

• Have a Montreal Cognitive Assessment (MoCA) score of greater than or equal to (≥) 24.

Locations
United States
California
Collaborative Neuroscience Network - CNS
NOT_YET_RECRUITING
Los Alamitos
Collaborative Neuroscience Network - CNS
NOT_YET_RECRUITING
Los Alamitos
Florida
K2 Medical Research, LLC
NOT_YET_RECRUITING
Maitland
Aqualane Clinical Research
NOT_YET_RECRUITING
Naples
Charter Research
NOT_YET_RECRUITING
Orlando
Progressive Medical Research
NOT_YET_RECRUITING
Port Orange
Charter Research
NOT_YET_RECRUITING
The Villages
K2 Medical Research, LLC
NOT_YET_RECRUITING
The Villages
Michigan
QUEST Research Institute
NOT_YET_RECRUITING
Farmington Hills
Texas
PPD Development, LP
RECRUITING
Austin
Washington
Evergreen Health Research
NOT_YET_RECRUITING
Kirkland
Other Locations
Japan
P-One Clinic
NOT_YET_RECRUITING
Hachiōji
Oita University Hospital
NOT_YET_RECRUITING
Yufu
Contact Information
Primary
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
LillyTrials@Lilly.com
1-317-615-4559
Backup
Physicians interested in becoming principal investigators please contact
clinical_inquiry_hub@lilly.com
Time Frame
Start Date: 2025-02-18
Estimated Completion Date: 2028-01
Participants
Target number of participants: 127
Treatments
Experimental: Part A LY4006896 + Placebo
Healthy participants will receive a single escalating dose of LY4006896 and matching placebo.
Experimental: Part B LY4006896 + Placebo
Participants with Parkinson's disease will receive multiple escalating doses of LY4006896 and matching placebo.
Related Therapeutic Areas
Sponsors
Leads: Eli Lilly and Company

This content was sourced from clinicaltrials.gov