Movement Disorders Clinical Trials

Find Movement Disorders Clinical Trials Near You

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 (14) 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
RECRUITING
Los Alamitos
Collaborative Neuroscience Network - CNS
RECRUITING
Los Alamitos
Florida
K2 Medical Research, LLC
COMPLETED
Maitland
Aqualane Clinical Research
RECRUITING
Naples
Charter Research
RECRUITING
Orlando
Progressive Medical Research
RECRUITING
Port Orange
Charter Research
RECRUITING
The Villages
K2 Medical Research, LLC
RECRUITING
The Villages
Michigan
QUEST Research Institute
RECRUITING
Farmington Hills
Texas
PPD Development, LP
RECRUITING
Austin
Washington
Evergreen Health Research
NOT_YET_RECRUITING
Kirkland
Inland Northwest Research
NOT_YET_RECRUITING
Spokane
Other Locations
Japan
P-One Clinic
RECRUITING
Hachiōji
Oita University Hospital
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