A Study to Evaluate Safety and Efficacy of KM-819 in Healthy Adults and Participants With Parkinson's Disease
Parkinson Disease
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring Inhibition of FAF1(Fas (TNFRSF6)-associated factor 1), Multiple Ascending Dose (MAD), Neuroprotection, Alpha-synuclein inhibition, KM-819
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 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.
Sites / Locations
- Parexel Early Phase Clinical UnitRecruiting
- University California San Diego Medical Center
- Quest Research Institute, Rose Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Part 1a: Cohort 1.1a Dose 400 mg
Part 1a: Cohort 1.2a Dose 600 mg
Part 1a: Cohort 1.3a Dose 800 mg
Part 1b: Cohort 1.1b Dose 200 mg
Part 1b: Cohort 1.2b Dose 400 mg
Part 1b: Cohort 1.3b Dose 600 mg
Part 2: Cohort 2.1 Dose X
Part 2: Cohort 2.2 Dose Y
Healthy older adult participants will receive oral 400 mg dose of KM-819 or matching placebo once-daily for 7 days, after fasting for 2 hours prior to administration of study intervention and will be required to fast for 1 hour after administration of study intervention.
Healthy older adult participants will receive oral 600 mg dose of KM-819 or matching placebo once-daily for 7 days, after fasting for 2 hours prior to administration of study intervention and will be required to fast for 1 hour after administration of study intervention.
Healthy older adult participants will receive oral 800 mg dose of KM-819 or matching placebo once-daily for 7 days, after fasting for 2 hours prior to administration of study intervention and will be required to fast for 1 hour after administration of study intervention.
Participants with Parkinson's disease will receive oral 200 mg dose of KM-819 or matching placebo once-daily for 7 days, after fasting for 2 hours prior to administration of study intervention and will be required to fast for 1 hour after administration of study intervention.
Participants with Parkinson's disease will receive oral 400 mg dose of KM-819 or matching placebo once-daily for 7 days, after fasting for 2 hours prior to administration of study intervention and will be required to fast for 1 hour after administration of study intervention.
Participants with Parkinson's disease will receive oral 600 mg dose of KM-819 or matching placebo once-daily for 7 days, after fasting for 2 hours prior to administration of study intervention and will be required to fast for 1 hour after administration of study intervention.
Participants with Parkinson's disease will receive oral doses of KM-819 (dose to be determined based on the findings from Part 1) or matching placebo once-daily for 730 days and will be allowed to take study intervention with or without fasting.
Participants with Parkinson's disease will receive oral doses of KM-819 (dose to be determined based on the findings from Part 1) or matching placebo once-daily for 730 days and will be allowed to take study intervention with or without fasting.