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RecruitingPhase 1

A Study of LY4006896 in Healthy Participants and Participants With Parkinson's Disease

A Single-Ascending Dose and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY4006896 in Healthy Participants and Participants With Parkinson's Disease

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
30 Years to 85 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 120 days, 35 days, 61 weeks, 78 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The screening period will be up to 120 days for participants with Parkinson's disease who receive up to 4 doses, and up to 35 days for healthy participants who receive 1 dose."
  • "The treatment and follow-up duration will be up to 61 weeks for participants with Parkinson's disease, and 48 weeks for healthy participants."
  • "The total study duration will be up to 78 weeks for participants with Parkinson's disease, and 53 weeks for healthy participants."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests LY4006896 given through a vein (IV) against a placebo, which has no study drug. It checks safety, side effects, and how the drug moves through and affects the body. It is for healthy adults ages 30–85 and adults with Parkinson’s disease ages 40–85.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Both parts: Have a body mass index (BMI), a measure of weight compared with height, of 18–34.
  • Both parts: Have veins suitable for blood draws or IV treatment, or both.
  • For Japanese participants: You, your birth parents, and all your birth grandparents must be of only Japanese descent and born in Japan.
  • Part A, which tests a single dose: Be healthy and age 30–85 when signing the consent form.
  • For Chinese participants in Part A: All four birth grandparents must be of only Chinese descent and born in China.
  • Part B, which tests repeated doses: Be age 40–85 when signing the consent form and have Parkinson’s disease diagnosed using the required guidelines.
  • Part B: If untreated, no change in treatment for Parkinson’s symptoms should be expected for 52 weeks. If treated, your dose of dopamine-related medicine must be stable for at least 90 days, with no change expected for 52 weeks.
  • Part B: Score at least 24 on the Montreal Cognitive Assessment (MoCA), a test of memory and thinking.

Who can't join

  • A major brain or spinal cord disease that could prevent you from finishing the study, other than Parkinson’s in Part B; or a serious or unstable illness that could affect study results, raise treatment risks, or mean you may live less than 24 months.
  • Allergies to LY4006896, related drugs, or its ingredients; past allergic reactions to transferrin receptor antibodies; or major allergies to humanized monoclonal antibodies. These antibodies are types of protein medicines.
  • Several major drug allergies, severe drug allergies, severe allergic reactions after treatment, or inability to tolerate steroid creams.
  • Uncontrolled asthma, a major disease in which the immune system attacks the body, inherited swelling attacks, or a known immune disorder called common variable immune deficiency.
  • Significant anemia, meaning too few healthy red blood cells; or an A1c blood sugar test result of 6.5% or higher.
  • Part A: Abnormal blood pressure or pulse, or a history of high blood pressure. Part B: Abnormal blood pressure or pulse, or blood pressure above 150 for the top number or 95 for the bottom number at screening or treatment visits.
  • Part B: An implanted device that uses electrical signals to stimulate the brain, spinal cord, or nerves.
  • Part B: Parkinson’s medicine given by a continuous infusion, such as through a pump under the skin or into the intestine.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: Part A Single Ascending Dose (SAD) and B Multiple Dose (MD) * Have a body mass index within the range of 18 to 34 kilogram per 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 (MD) 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. Exclusion Criteria: Part A (SAD) and B (MD) * 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 result in a participant's life expectancy of less than 24 months. * 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 intolerance to topical corticosteroids, or severe posttreatment hypersensitivity reactions. * 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 (MD) 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 greater than (\>) 150 mmHg or a diastolic blood pressure \>95 mmHg at Screening or Treatment Visits. * 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 devices) * Are receiving continuous infusion therapy with anti-parkinsonian medications, including but not limited to subcutaneous foslevodopa-foscarbidopa, subcutaneous apomorphine, or intraduodenal/intestinal levodopa formulations Diagnostic assessments * Hemoglobin A1c 6.5 percent (%) or higher

Study sites (12)

CA

FL

MI

TX

WA