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Recruiting NCT05670782

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

Conditions: Parkinson Disease

Sex: All
Ages: 40 Years – N/A
Healthy volunteers: 1
Phase: PHASE2
Enrollment: 330
Sponsor: FAScinate Therapeutics Inc.

Location: United States

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.

Eligibility 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 randomizationPresence of idiopathic Parkinson's disease Hoehn and Yahr Stage ≤ 4History 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 ScreeningBody 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 periodA female participant is eligible to participate if she is not pregnant, not breastfeedingExclusion Criteria:Diagnosis of neurodegenerative disorder other than idiopathic Parkinson's disease resulting in dementia or atypical parkinsonismLife-time history of a suicide attempt as determined by the Columbia-Suicide Severity Rating Scale (C-SSRS) for the ScreeningEvidence 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 dyskinesiaPrior surgical treatment for Parkinson's diseaseClinically 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05670782). StuddyBuddy aggregates publicly available trial information.