A Study to Evaluate Safety and Efficacy of KM-819 in Healthy Adults and Participants With Parkinson's Disease

• Status: Recruiting
• Trial end date: 2025-11-13
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this study is to test KM-819 in halting or slowing the progression of Parkinson's disease.

The study evaluates the safety and tolerability of multiple ascending doses of KM-819 in healthy older adults and participants with Parkinson's disease.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: FAScinate Therapeutics Inc.
• Collaborator: Parexel

Criteria

Inclusion Criteria:

• Participant is a healthy volunteer or has a clinical diagnosis of idiopathic Parkinson's disease.

• Participant is on a stable dose of medications to treat Parkinson's disease at least 8 weeks prior to randomization

• Presence of idiopathic Parkinson's disease Hoehn and Yahr Stage ≤ 4

• History or current use of dopamine/dopaminergic drugs, levodopa with decarboxylase inhibitor or dopaminergic agonists, with a stable dosage for at least 30 days prior to Screening

• Body mass index (BMI) within the range 18.5 to 35 kg/m2 (inclusive)

• A male participant must not have a pregnant or breastfeeding partner and must agree to use a highly effective contraception method starting from Screening and refrain from donating sperm during this period

• A female participant is eligible to participate if she is not pregnant, not breastfeeding

Exclusion Criteria:

• Diagnosis of neurodegenerative disorder other than idiopathic Parkinson's disease resulting in dementia or atypical parkinsonism

• Life-time history of a suicide attempt as determined by the Columbia-Suicide Severity Rating Scale (C-SSRS) for the Screening

• Evidence of cognitive decline defined by the Montreal Cognitive Assessment (MoCA) score ≤25 for healthy normal population (Part 1a) and ≤21 for the patient population (Part 1b and Part 2)

• History of levodopa-induced motor fluctuations or dyskinesia

• Prior surgical treatment for Parkinson's disease

• Clinically significant brain abnormalities on or contraindication to a structural magnetic resonance imaging (MRI)

• Significant respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, pancreatic, musculoskeletal, genitourinary, immunological or dermatological disorders.