A Study to Evaluate Safety and Efficacy of KM-819 in Healthy Adults and Participants with Parkinson's Disease
NCT ID: NCT05670782
Last Updated: 2025-03-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
314 participants
INTERVENTIONAL
2022-07-19
2025-11-13
Brief Summary
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The study evaluates the safety and tolerability of multiple ascending doses of KM-819 in healthy older adults and participants with Parkinson's disease.
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Detailed Description
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Part 1 of this study will evaluate the safety, tolerability and plasma PK of multiple ascending doses (MAD) of KM-819 in healthy older adults (Part 1a) and participants with Parkinson's disease (Part 1b).
* Part 1a is a randomized, double-blind, Multiple Ascending Dose (MAD) study in healthy older adults that will include 3 cohorts.
* Part 1b is a randomized, double-blind, MAD study in participants with Parkinson's disease that will include 3 cohorts.
Part 2 of the study is a randomized, double-blind, multiple dose study in participants with Parkinson's disease that will include 2 cohorts. It is designed to test the safety, tolerability, plasma PK and pharmacodynamic effects of KM-819 in participants with Parkinson's disease. The study will also assess the degree to which those treated with KM-819 will experience gains in overall daily function within the context of improved Parkinson's disease motor and non-motor symptoms in comparison to placebo. Participants will be randomized to receive KM-819 or matching placebo at doses to be determined based on the findings from Part 1 in a 2:1 ratio.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
DOUBLE
Study Groups
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Part 1a: Cohort 1.1a Dose 400 mg
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.
KM-819
Participants will receive oral doses of KM-819 once-daily
Placebo
Participants will receive matching placebo once-daily
Part 1a: Cohort 1.2a Dose 600 mg
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.
KM-819
Participants will receive oral doses of KM-819 once-daily
Placebo
Participants will receive matching placebo once-daily
Part 1a: Cohort 1.3a Dose 800 mg
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.
KM-819
Participants will receive oral doses of KM-819 once-daily
Placebo
Participants will receive matching placebo once-daily
Part 1b: Cohort 1.1b Dose 200 mg
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.
KM-819
Participants will receive oral doses of KM-819 once-daily
Placebo
Participants will receive matching placebo once-daily
Part 1b: Cohort 1.2b Dose 400 mg
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.
KM-819
Participants will receive oral doses of KM-819 once-daily
Placebo
Participants will receive matching placebo once-daily
Part 1b: Cohort 1.3b Dose 600 mg
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.
KM-819
Participants will receive oral doses of KM-819 once-daily
Placebo
Participants will receive matching placebo once-daily
Part 2: Cohort 2.1 Dose X
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.
KM-819
Participants will receive oral doses of KM-819 once-daily
Placebo
Participants will receive matching placebo once-daily
Part 2: Cohort 2.2 Dose Y
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.
KM-819
Participants will receive oral doses of KM-819 once-daily
Placebo
Participants will receive matching placebo once-daily
Interventions
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KM-819
Participants will receive oral doses of KM-819 once-daily
Placebo
Participants will receive matching placebo once-daily
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
40 Years
ALL
Yes
Sponsors
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Parexel
INDUSTRY
FAScinate Therapeutics Inc.
INDUSTRY
Responsible Party
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Locations
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Parexel Early Phase Clinical Unit
Glendale, California, United States
University California San Diego Medical Center
San Diego, California, United States
Quest Research Institute, Rose Cancer Center
Royal Oak, Michigan, United States
Countries
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Other Identifiers
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FASCP-819-K103
Identifier Type: -
Identifier Source: org_study_id
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