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New treatment option for Parkinson Disease
Official title A Study of LY4006896 in Healthy Participants and Participants With Parkinson's Disease
ClinicalTrials.gov ID: NCT06809400
What this study is testing
What is LY4006896?
LY4006896 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for parkinson disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 to 85. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- 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
You likely can't join if
- Part A (SAD) and B (MAD)
- Have significant neurological disease affecting the central nervous system (CNS) (other than Parkinson's disease in Part B cohorts) that may affect...
- Have a history or presence of serious or unstable illnesses or conditions that, in the investigator's opinion, could interfere with the analyses in...
- Have known allergies to LY4006896, related compounds, or any components of the formulation, or history of allergic reactions to any transferrin...
- Have significant allergies to humanize monoclonal antibodies.
- Have clinically significant multiple or severe drug allergies (including, but not limited to, erythema multiforme major, linear immunoglobulin A...
See the full eligibility criteria
- 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...
- 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...
- Have a Montreal Cognitive Assessment (MoCA) score of greater than or equal to (≥) 24.
- Part A (SAD) and B (MAD)
- Have significant neurological disease affecting the central nervous system (CNS) (other than Parkinson's disease in Part B cohorts) that may affect the participant's ability to complete the study.
- Have a history or presence of serious or unstable illnesses or conditions that, in the investigator's opinion, could interfere with the analyses in this study, or increase risk for study intervention administration, or...
- Have known allergies to LY4006896, related compounds, or any components of the formulation, or history of allergic reactions to any transferrin receptor antibodies.
- Have significant allergies to humanize monoclonal antibodies.
- Have clinically significant multiple or severe drug allergies (including, but not limited to, erythema multiforme major, linear immunoglobulin A dermatosis, toxic epidermal necrolysis, or exfoliative dermatitis); or...
- Have history or presence of uncontrolled asthma, significant autoimmune disease, hereditary angioedema, or known history of common variable immune deficiency.
- Evidence of clinically significant anemia. Part A (SAD) Only
- Have an abnormal blood pressure or pulse rate, or both, as determined by the investigator, or a preexisting history of hypertension. Part B (MAD) Only
- Have an abnormal blood pressure or pulse rate, or both, as determined by the investigator, or have uncontrolled hypertension, defined as a systolic blood pressure \>150 mm Hg or a diastolic blood pressure \>95 mm Hg at...
- Have an implanted deep brain stimulation (DBS) system or any other implanted neurostimulation device (including but not limited to spinal cord stimulation, vagus nerve stimulation or investigational neuromodulation...
- Are receiving continuous infusion therapy with anti-parkinsonian medications, including but not limited to subcutaneous foslevodopa-foscarbidopa, subcutaneous apomorphine, or intraduodenal/intestinal levodopa...
The study team makes the final eligibility decision.
Where it's taking place
- Los Alamitos, California, United States
- Maitland, Florida, United States
- Naples, Florida, United States
- Orlando, Florida, United States
- Port Orange, Florida, United States
- The Villages, Florida, United States
- Farmington Hills, Michigan, United States
- Austin, Texas, United States
- Kirkland, Washington, United States
- Spokane, Washington, United States
- Hachiōji, Japan
- Yufu, Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 30 years to 85 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Alamitos, California, United States; Maitland, Florida, United States; Naples, Florida, United States; Orlando, Florida, United States; Port Orange, Florida, United States; The Villages, Florida, United States and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.