A Clinical Trial of LY3962681 in Healthy Volunteers and in Patients With Parkinson's Disease

Part of paid clinical trials in Austin, Texas.

Sponsor
Prevail Therapeutics
Study ID
NCT06565195
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
30 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • LY3962681 — DRUG
    IT injection
  • Placebo (aCSF) — OTHER
    IT injection

Study Details

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics/pharmacodynamics (PK/PD) of LY3962681 in healthy volunteers and patients with Parkinson's disease. The study consists of two parts, the Single Ascending Dose (SAD) study and the Multiple Ascending Dose (MAD) study. During the SAD portion of the study, healthy volunteers will receive a single dose of LY3962681 or placebo (artificial cerebrospinal fluid \[aCSF\]) administered intrathecally (into the spinal fluid). During the MAD portion of the study, patients with Parkinson's disease will receive two doses of either LY3962681 or placebo (aCSF) administered intrathecally (into the spinal fluid), 12 to 24 weeks apart. * The treatment period in the SAD study will be 1 day. The treatment period in the MAD study will be 2 dosing days, 12 to 24 weeks apart. * The follow-up period in the SAD study will be up to 52 weeks. The follow-up period in the MAD study will be up to 52 weeks after Dose 2.

Key Dates

Start date
Aug 27, 2024
Status verified
Mar 2026
Primary completion
May 5, 2029
Completion
May 5, 2029

Study Design

Enrollment
124 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: LY3962681 (SAD)
    Single ascending dose of LY3962681 or placebo (aCSF) administered intrathecally (IT) to healthy volunteers.
  • Experimental: LY3962681 (MAD)
    Multiple ascending doses of LY3962681 or placebo (aCSF) administered IT to participants with Parkinson's disease.

Primary Outcome Measure

Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to 76 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Austin Clinic PPDAustinTexas78744-1625
Ashley Pham
[email protected]
512-447-2985

Find similar trials in Austin, TX

By condition
Parkinson's disease
By specialty
NeurologyBrain disorders
By research site
Austin Clinic PPD· Austin, TX

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