This study is in progress, not accepting new patients

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

a study on Parkinson's Disease

Summary

Eligibility
for people ages 40 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Location
at San Diego, California and other locations
Dates
study started
completion around

Description

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.

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

Details

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.

Keywords

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

Eligibility

You can join if…

Open to people ages 40 years and up

  • 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

You CAN'T join if...

  • 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.

Locations

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

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
FAScinate Therapeutics Inc.
ID
NCT05670782
Phase
Phase 2 Parkinson's Disease Research Study
Study Type
Interventional
Participants
Expecting 314 study participants
Last Updated