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

Primary Purpose

Parkinson Disease

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
KM-819
Placebo
Sponsored by
FAScinate Therapeutics Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

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

40 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

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

Arm Description

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.

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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
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
Part 1a and 1b: Maximum concentration (Cmax)
To evaluate the pharmacokinetics (PK) of multiple ascending doses (MAD) of KM-819 in plasma
Part 1a and 1b: Time to achieve Cmax (tmax)
To evaluate the pharmacokinetics (PK) of multiple ascending doses (MAD) of KM-819 in plasma
Part 1a and 1b: Minimum concentration (Cmin)
To evaluate the pharmacokinetics (PK) of multiple ascending doses (MAD) of KM-819 in plasma
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
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
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
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
Part 1a and 1b: Terminal elimination rate constant (λz)
To evaluate the pharmacokinetics (PK) of multiple ascending doses (MAD) of KM-819 in plasma
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
Part 1a and 1b: Apparent oral clearance (CL/F)
To evaluate the pharmacokinetics (PK) of multiple ascending doses (MAD) of KM-819 in plasma
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Part 1a and 1b: Renal clearance (CLR)
To evaluate the pharmacokinetics (PK) of multiple ascending doses (MAD) of KM-819 in urine
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.

Full Information

First Posted
December 21, 2022
Last Updated
August 31, 2023
Sponsor
FAScinate Therapeutics Inc.
Collaborators
Parexel
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1. Study Identification

Unique Protocol Identification Number
NCT05670782
Brief Title
A Study to Evaluate Safety and Efficacy of KM-819 in Healthy Adults and Participants With Parkinson's Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 19, 2022 (Actual)
Primary Completion Date
October 30, 2025 (Anticipated)
Study Completion Date
November 13, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
FAScinate Therapeutics Inc.
Collaborators
Parexel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Inhibition of FAF1(Fas (TNFRSF6)-associated factor 1), Multiple Ascending Dose (MAD), Neuroprotection, Alpha-synuclein inhibition, KM-819

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Masking
ParticipantInvestigator
Masking Description
Double-Blinded
Allocation
Randomized
Enrollment
330 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Part 1a: Cohort 1.1a Dose 400 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Part 1a: Cohort 1.2a Dose 600 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Part 1a: Cohort 1.3a Dose 800 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Part 1b: Cohort 1.1b Dose 200 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Part 1b: Cohort 1.2b Dose 400 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Part 1b: Cohort 1.3b Dose 600 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Part 2: Cohort 2.1 Dose X
Arm Type
Experimental
Arm Description
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.
Arm Title
Part 2: Cohort 2.2 Dose Y
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
KM-819
Intervention Description
Participants will receive oral doses of KM-819 once-daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants will receive matching placebo once-daily
Primary Outcome Measure Information:
Title
Part 1a,1b and 2: Number of participants with adverse events and serious adverse events
Description
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
Title
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
Description
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 Outcome Measure Information:
Title
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)
Description
To evaluate the pharmacokinetics (PK) of multiple ascending doses (MAD) of KM-819 in plasma
Time Frame
Day 1
Title
Part 1a and 1b: AUC from pre-dose (time zero) to 24 hours post-dose [AUC(0-24)]
Description
To evaluate the pharmacokinetics (PK) of multiple ascending doses (MAD) of KM-819 in plasma
Time Frame
Day 1
Title
Part 1a and 1b: Maximum concentration (Cmax)
Description
To evaluate the pharmacokinetics (PK) of multiple ascending doses (MAD) of KM-819 in plasma
Time Frame
Day 1
Title
Part 1a and 1b: Time to achieve Cmax (tmax)
Description
To evaluate the pharmacokinetics (PK) of multiple ascending doses (MAD) of KM-819 in plasma
Time Frame
Day 1
Title
Part 1a and 1b: Minimum concentration (Cmin)
Description
To evaluate the pharmacokinetics (PK) of multiple ascending doses (MAD) of KM-819 in plasma
Time Frame
Day 1
Title
Part 1a and 1b: AUC normalized to dose administered (AUC_D)
Description
To evaluate the pharmacokinetics (PK) of multiple ascending doses (MAD) of KM-819 in plasma
Time Frame
Day 1
Title
Part 1a and 1b: Cmax normalized to dose administered (Cmax_D)
Description
To evaluate the pharmacokinetics (PK) of multiple ascending doses (MAD) of KM-819 in plasma
Time Frame
Day 1
Title
Part 1a and 1b: AUC from pre-dose (time zero) extrapolated to time infinity [AUC(0-inf)]
Description
To evaluate the pharmacokinetics (PK) of multiple ascending doses (MAD) of KM-819 in plasma
Time Frame
Day 1
Title
Part 1a and 1b: Apparent terminal elimination half-life (t½)
Description
To evaluate the pharmacokinetics (PK) of multiple ascending doses (MAD) of KM-819 in plasma
Time Frame
Day 1
Title
Part 1a and 1b: Terminal elimination rate constant (λz)
Description
To evaluate the pharmacokinetics (PK) of multiple ascending doses (MAD) of KM-819 in plasma
Time Frame
Day 1
Title
Part 1a and 1b: Percentage of AUCinf that is extrapolated beyond the time of the last quantifiable concentration [%AUC (extrap)]
Description
To evaluate the pharmacokinetics (PK) of multiple ascending doses (MAD) of KM-819 in plasma
Time Frame
Day 1
Title
Part 1a and 1b: Apparent oral clearance (CL/F)
Description
To evaluate the pharmacokinetics (PK) of multiple ascending doses (MAD) of KM-819 in plasma
Time Frame
Day 1
Title
Part 1a and 1b: AUC(0-t) at steady state (Vz/F)
Description
To evaluate the pharmacokinetics (PK) of multiple ascending doses (MAD) of KM-819 in plasma
Time Frame
Day 1
Title
Part 1a and 1b: AUC(0-t) at steady state [AUC(0-t_ss)]
Description
To evaluate the pharmacokinetics (PK) of multiple ascending doses (MAD) of KM-819 in plasma
Time Frame
Day 7
Title
Part 1a and 1b: AUCtau at steady state [AUC(tau_ss)]
Description
To evaluate the pharmacokinetics (PK) of multiple ascending doses (MAD) of KM-819 in plasma
Time Frame
Day 7
Title
Part 1a and 1b: Cmax at steady state (Cmax,ss)
Description
To evaluate the pharmacokinetics (PK) of multiple ascending doses (MAD) of KM-819 in plasma
Time Frame
Day 7
Title
Part 1a and 1b: tmax at steady state (tmax,ss)
Description
To evaluate the pharmacokinetics (PK) of multiple ascending doses (MAD) of KM-819 in plasma
Time Frame
Day 7
Title
Part 1a and 1b: Ctrough at steady state (Ctrough_ss)
Description
To evaluate the pharmacokinetics (PK) of multiple ascending doses (MAD) of KM-819 in plasma
Time Frame
Day 7
Title
Part 1a and 1b: Minimum concentration at steady state (Cmin,ss)
Description
To evaluate the pharmacokinetics (PK) of multiple ascending doses (MAD) of KM-819 in plasma
Time Frame
Day 7
Title
Part 1a and 1b: Average observed concentration at steady state (Cav,ss)
Description
To evaluate the pharmacokinetics (PK) of multiple ascending doses (MAD) of KM-819 in plasma
Time Frame
Day 7
Title
Part 1a and 1b: Accumulation ratio calculated using AUC [Rac (AUC)]
Description
To evaluate the pharmacokinetics (PK) of multiple ascending doses (MAD) of KM-819 in plasma
Time Frame
Day 7
Title
Part 1a and 1b: Accumulation ratio calculated using Cmax [Rac (Cmax)]
Description
To evaluate the pharmacokinetics (PK) of multiple ascending doses (MAD) of KM-819 in plasma
Time Frame
Day 7
Title
Part 1a and 1b: Apparent oral clearance at steady state (CL/Fss)
Description
To evaluate the pharmacokinetics (PK) of multiple ascending doses (MAD) of KM-819 in plasma
Time Frame
Day 7
Title
Part 1a and 1b: AUC normalized to dose administered at steady state (AUCss_D)
Description
To evaluate the pharmacokinetics (PK) of multiple ascending doses (MAD) of KM-819 in plasma
Time Frame
Day 7
Title
Part 1a and 1b: Cmax_ss normalized to dose administered (Cmaxss_D)
Description
To evaluate the pharmacokinetics (PK) of multiple ascending doses (MAD) of KM-819 in plasma
Time Frame
Day 7
Title
Part 1a and 1b: Fraction of dose excreted in urine (Fe)
Description
To evaluate the pharmacokinetics (PK) of multiple ascending doses (MAD) of KM-819 in urine
Time Frame
Day 7
Title
Part 1a and 1b: Renal clearance (CLR)
Description
To evaluate the pharmacokinetics (PK) of multiple ascending doses (MAD) of KM-819 in urine
Time Frame
Day 7
Title
Part 2: Sparse plasma PK blood sampling for population PK analysis
Description
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 Pre-specified Outcome Measures:
Title
Digital biomarkers using the Parkinson's Disease Digital Biomarker Solutions from Roche Molecular Solutions.
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
JAE MOON LEE
Phone
(858)630-8540
Email
jmlee@fascinatetherapeutics.com
First Name & Middle Initial & Last Name or Official Title & Degree
Briana Lee
Phone
(858)630-8543
Email
bblee@fascinatetherapeutics.com
Facility Information:
Facility Name
Parexel Early Phase Clinical Unit
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Individual Site Status
Recruiting
Facility Name
University California San Diego Medical Center
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Quest Research Institute, Rose Cancer Center
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Individual Site Status
Enrolling by invitation

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Individual Identifiable personal information will not be shared. All individuals will be coded.

Learn more about this trial

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

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