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Parkinson DiseasePhase 2NCT05670782

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

A Phase 2 study testing KM-819 in people with Parkinson Disease, run by FAScinate Therapeutics Inc. at 3 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 more about this study

Who is it for?
Ages 40 years and olderHealthy volunteers can take part
Conditions the study is for
Parkinson Disease
What is being tested?
KM-819
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
314 participants
Where
3 sitesUnited States
Study dates
19 Jul 2022to 13 Nov 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Parexel Early Phase Clinical Unit

    Glendale, California, 91206

  • Quest Research Institute, Rose Cancer Center

    Royal Oak, Michigan, 48073

  • University California San Diego Medical Center

    San Diego, California, 92103

Other trials in United States

About this study

Official title: A Phase 2 Study Evaluating the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of KM-819 in Healthy Older Adults and Participants with Parkinson's Disease

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.

Being tested
KM-819, Placebo
Keywords
Inhibition of FAF1(Fas (TNFRSF6)-associated factor 1), Multiple Ascending Dose (MAD), Neuroprotection, Alpha-synuclein inhibition, KM-819
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KM-819Drug

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

  • PlaceboDrug

    Participants will receive matching placebo once-daily

Study groups in NCT05670782
Study groupRoleWhat they receive
Part 1a: Cohort 1.1a Dose 400 mgExperimentalHealthy 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.
Receives: Drug: KM-819; Drug: Placebo
Part 1a: Cohort 1.2a Dose 600 mgExperimentalHealthy 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.
Receives: Drug: KM-819; Drug: Placebo
Part 1a: Cohort 1.3a Dose 800 mgExperimentalHealthy 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.
Receives: Drug: KM-819; Drug: Placebo
Part 1b: Cohort 1.1b Dose 200 mgExperimentalParticipants 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.
Receives: Drug: KM-819; Drug: Placebo
Part 1b: Cohort 1.2b Dose 400 mgExperimentalParticipants 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.
Receives: Drug: KM-819; Drug: Placebo
Part 1b: Cohort 1.3b Dose 600 mgExperimentalParticipants 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.
Receives: Drug: KM-819; Drug: Placebo
Part 2: Cohort 2.1 Dose XExperimentalParticipants 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.
Receives: Drug: KM-819; Drug: Placebo
Part 2: Cohort 2.2 Dose YExperimentalParticipants 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.
Receives: Drug: KM-819; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 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

    Measured: From screening (Day -42 to -2) to Day 730

Secondary outcomes (28)

  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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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.

    Measured: Day 1, Day 7, Day 30 and Day 180

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jan 2023
  2. Study start19 Jul 2022
  3. Primary completion30 Oct 2025 (estimated)
  4. Study completion13 Nov 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
314 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05670782
Sponsor's protocol ID
FASCP-819-K103
Status last verified
Jun 2024
First submitted
21 Dec 2022
Last updated
5 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided: Individual Identifiable personal information will not be shared. All individuals will be coded.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing KM-819 in people with Parkinson Disease, run by FAScinate Therapeutics Inc. at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1a,1b and 2: Number of participants with adverse events and serious adverse events (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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05670782.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2025.

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