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Active, not recruitingNCT05670782Updated Mar 5, 2025

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

A Phase 2 interventional study of KM-819 and Placebo in Parkinson Disease, sponsored by FAScinate Therapeutics Inc.. Active, not recruiting at 3 sites in United States. Open to participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-05.

Sponsored by FAScinate Therapeutics Inc. · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Oct 2025, 11 months ago, but the record still lists the study as active, not recruiting.
  • Registered 5 months after the study started (first participant enrolled Jul 2022, registered Dec 2022).
Phase
Phase 2
Study type
Interventional
Enrollment
314
Allocation
Randomized
Ages
40 Years and older
Sex
All
01

Study 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.

Read the detailed description

The overall study will consist of three parts (Part 1a, Part 1b and Part 2).

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.

02

Conditions studied

  • Parkinson Disease

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Keywords

  • Inhibition of FAF1(Fas (TNFRSF6)-associated factor 1)
  • Multiple Ascending Dose (MAD)
  • Neuroprotection
  • Alpha-synuclein inhibition
  • KM-819
03

In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

This study's planned enrollment of 314 is above the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

This is the only study on the registry with FAScinate Therapeutics Inc. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Double (Participant, Investigator)
Enrollment
314 participants (estimated)

Study arms

  • Experimental
    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.

    Drug: KM-819 · Drug: Placebo

  • Experimental
    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.

    Drug: KM-819 · Drug: Placebo

  • Experimental
    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.

    Drug: KM-819 · Drug: Placebo

  • Experimental
    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.

    Drug: KM-819 · Drug: Placebo

  • Experimental
    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.

    Drug: KM-819 · Drug: Placebo

  • Experimental
    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.

    Drug: KM-819 · Drug: Placebo

  • Experimental
    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.

    Drug: KM-819 · Drug: Placebo

  • Experimental
    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.

    Drug: KM-819 · Drug: Placebo

Interventions

  • DrugKM-819

    Participants will receive oral doses of KM-819 once-daily

  • DrugPlacebo

    Participants will receive matching placebo once-daily

06

What researchers measure

Primary outcomes

  1. Part 1a,1b and 2: Number of participants with adverse events and serious adverse events

    To evaluate the safety and tolerability of multiple ascending doses of KM-819

    Time frame: Part 1a and Part 1b: From screening (Day -42 to -3) up to 7 days and Part 2: From screening (Day -42 to -2) to 730 days

  2. Part 2: Change from baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II: Activities of Daily Living (ADL) Score at Day 730

    Activities of Daily living (ADL) will be assessed via MDS-UPDRS score. MDS-UPDRS Part II is a self-administered questionnaire that assesses the motor experience of daily living in participants with Parkinson's disease. Score: 0: Normal, 1: Slight, 2: Mild, 3: Moderate, 4: Severe. Higher the score, the more severe the condition or symptom

    Time frame: From screening (Day -42 to -2) to Day 730

Secondary outcomes

  1. Part 1a and 1b: Area under the concentration-time curve (AUC) from pre-dose (time zero) to the time of the last quantifiable concentration AUC(0-t)

    To evaluate the pharmacokinetics (PK) of multiple ascending doses (MAD) of KM-819 in plasma

    Time frame: Day 1

  2. Part 1a and 1b: AUC from pre-dose (time zero) to 24 hours post-dose [AUC(0-24)]

    To evaluate the pharmacokinetics (PK) of multiple ascending doses (MAD) of KM-819 in plasma

    Time frame: Day 1

  3. Part 1a and 1b: Maximum concentration (Cmax)

    To evaluate the pharmacokinetics (PK) of multiple ascending doses (MAD) of KM-819 in plasma

    Time frame: Day 1

  4. Part 1a and 1b: Time to achieve Cmax (tmax)

    To evaluate the pharmacokinetics (PK) of multiple ascending doses (MAD) of KM-819 in plasma

    Time frame: Day 1

  5. Part 1a and 1b: Minimum concentration (Cmin)

    To evaluate the pharmacokinetics (PK) of multiple ascending doses (MAD) of KM-819 in plasma

    Time frame: Day 1

  6. Part 1a and 1b: AUC normalized to dose administered (AUC_D)

    To evaluate the pharmacokinetics (PK) of multiple ascending doses (MAD) of KM-819 in plasma

    Time frame: Day 1

  7. Part 1a and 1b: Cmax normalized to dose administered (Cmax_D)

    To evaluate the pharmacokinetics (PK) of multiple ascending doses (MAD) of KM-819 in plasma

    Time frame: Day 1

  8. Part 1a and 1b: AUC from pre-dose (time zero) extrapolated to time infinity [AUC(0-inf)]

    To evaluate the pharmacokinetics (PK) of multiple ascending doses (MAD) of KM-819 in plasma

    Time frame: Day 1

  9. Part 1a and 1b: Apparent terminal elimination half-life (t½)

    To evaluate the pharmacokinetics (PK) of multiple ascending doses (MAD) of KM-819 in plasma

    Time frame: Day 1

  10. Part 1a and 1b: Terminal elimination rate constant (λz)

    To evaluate the pharmacokinetics (PK) of multiple ascending doses (MAD) of KM-819 in plasma

    Time frame: Day 1

  11. Part 1a and 1b: Percentage of AUCinf that is extrapolated beyond the time of the last quantifiable concentration [%AUC (extrap)]

    To evaluate the pharmacokinetics (PK) of multiple ascending doses (MAD) of KM-819 in plasma

    Time frame: Day 1

  12. Part 1a and 1b: Apparent oral clearance (CL/F)

    To evaluate the pharmacokinetics (PK) of multiple ascending doses (MAD) of KM-819 in plasma

    Time frame: Day 1

  13. Part 1a and 1b: AUC(0-t) at steady state (Vz/F)

    To evaluate the pharmacokinetics (PK) of multiple ascending doses (MAD) of KM-819 in plasma

    Time frame: Day 1

  14. Part 1a and 1b: AUC(0-t) at steady state [AUC(0-t_ss)]

    To evaluate the pharmacokinetics (PK) of multiple ascending doses (MAD) of KM-819 in plasma

    Time frame: Day 7

  15. Part 1a and 1b: AUCtau at steady state [AUC(tau_ss)]

    To evaluate the pharmacokinetics (PK) of multiple ascending doses (MAD) of KM-819 in plasma

    Time frame: Day 7

  16. Part 1a and 1b: Cmax at steady state (Cmax,ss)

    To evaluate the pharmacokinetics (PK) of multiple ascending doses (MAD) of KM-819 in plasma

    Time frame: Day 7

  17. Part 1a and 1b: tmax at steady state (tmax,ss)

    To evaluate the pharmacokinetics (PK) of multiple ascending doses (MAD) of KM-819 in plasma

    Time frame: Day 7

  18. Part 1a and 1b: Ctrough at steady state (Ctrough_ss)

    To evaluate the pharmacokinetics (PK) of multiple ascending doses (MAD) of KM-819 in plasma

    Time frame: Day 7

  19. Part 1a and 1b: Minimum concentration at steady state (Cmin,ss)

    To evaluate the pharmacokinetics (PK) of multiple ascending doses (MAD) of KM-819 in plasma

    Time frame: Day 7

  20. Part 1a and 1b: Average observed concentration at steady state (Cav,ss)

    To evaluate the pharmacokinetics (PK) of multiple ascending doses (MAD) of KM-819 in plasma

    Time frame: Day 7

  21. Part 1a and 1b: Accumulation ratio calculated using AUC [Rac (AUC)]

    To evaluate the pharmacokinetics (PK) of multiple ascending doses (MAD) of KM-819 in plasma

    Time frame: Day 7

  22. Part 1a and 1b: Accumulation ratio calculated using Cmax [Rac (Cmax)]

    To evaluate the pharmacokinetics (PK) of multiple ascending doses (MAD) of KM-819 in plasma

    Time frame: Day 7

  23. Part 1a and 1b: Apparent oral clearance at steady state (CL/Fss)

    To evaluate the pharmacokinetics (PK) of multiple ascending doses (MAD) of KM-819 in plasma

    Time frame: Day 7

  24. Part 1a and 1b: AUC normalized to dose administered at steady state (AUCss_D)

    To evaluate the pharmacokinetics (PK) of multiple ascending doses (MAD) of KM-819 in plasma

    Time frame: Day 7

  25. Part 1a and 1b: Cmax_ss normalized to dose administered (Cmaxss_D)

    To evaluate the pharmacokinetics (PK) of multiple ascending doses (MAD) of KM-819 in plasma

    Time frame: Day 7

  26. Part 1a and 1b: Fraction of dose excreted in urine (Fe)

    To evaluate the pharmacokinetics (PK) of multiple ascending doses (MAD) of KM-819 in urine

    Time frame: Day 7

  27. Part 1a and 1b: Renal clearance (CLR)

    To evaluate the pharmacokinetics (PK) of multiple ascending doses (MAD) of KM-819 in urine

    Time frame: Day 7

  28. Part 2: Sparse plasma PK blood sampling for population PK analysis

    Sparse plasma population PK sampling will be collected, and population PK modeling will be used to characterize the PK of KM-819 in participants with Parkinson's disease.

    Time frame: Day 1, Day 7, Day 30 and Day 180

Other outcomes

  1. Digital biomarkers using the Parkinson's Disease Digital Biomarker Solutions from Roche Molecular Solutions.

    Measurements of active and passive monitoring of Parkinson's disease symptoms utilizing smartphone based devices and software

    Time frame: From screening (Day -42 to -2) to 2 years

07

Study locations

3 sites
  • Parexel Early Phase Clinical Unit
    Glendale, California 91206, United States
  • University California San Diego Medical Center
    San Diego, California 92103, United States
  • Quest Research Institute, Rose Cancer Center
    Royal Oak, Michigan 48073, United States
08

References and documents

Individual participant data

Plan to share: Undecided — Individual Identifiable personal information will not be shared. All individuals will be coded.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05670782
Lead sponsor
FAScinate Therapeutics Inc.
Collaborators
Parexel
Responsible party
Sponsor
First posted
Jan 4, 2023
Start date
Jul 19, 2022
Primary completion
Oct 30, 2025 (estimated)
Completion
Nov 13, 2025 (estimated)
Last update
Mar 5, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is active, not recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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