Health TrialsbyHealthPanel

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

ConditionParkinson Disease
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age30-85
SponsorEli Lilly and Company

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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.

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • LY4006896

    Drug

    Administered intravenously (IV)

  • Placebo

    Drug

    Administered IV

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: Part A LY4006896 + PlaceboExperimental treatment 1 intervention
Group B: Part B LY4006896 + PlaceboExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of Participants with One or More Serious Adverse Event(s) (SAEs) Part A

Time frame
Baseline to Week 48
2

Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs) Part A

Time frame
Baseline to Week 48
3

Number of Participants with One or More SAEs Part B

Time frame
Baseline to Week 61
4

Number of Participants with One or More TEAEs Part B

Time frame
Baseline to Week 61

Secondary outcomes

1

Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4006896 ARC-Associated Antisense Part A

Time frame
Baseline to Week 48
2

PK: Cmax of LY4006896 ARC-Associated Antisense Part B

Time frame
Baseline to Week 61
3

PK: Area Under the Concentration versus Time Curve (AUC) of LY4006896 ARC-Associated Antisense Part A

Time frame
Baseline to Week 48
4

PK: AUC of LY4006896 ARC-Associated Antisense Part B

Time frame
Baseline to Week 61

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eli Lilly and Company

Lead sponsor

Source ClinicalTrials.gov
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