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.
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 28 Secondary · Reporting Duration: 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
Day 1
Part 1a and 1b: AUC from pre-dose (time zero) extrapolated to time infinity [AUC(0-inf)]
Part 1a and 1b: AUC from pre-dose (time zero) to 24 hours post-dose [AUC(0-24)]
Part 1a and 1b: AUC normalized to dose administered (AUC_D)
Part 1a and 1b: AUC(0-t) at steady state (Vz/F)
Part 1a and 1b: Apparent oral clearance (CL/F)
Part 1a and 1b: Apparent terminal elimination half-life (t½)
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)
Part 1a and 1b: Cmax normalized to dose administered (Cmax_D)
Part 1a and 1b: Maximum concentration (Cmax)
Part 1a and 1b: Minimum concentration (Cmin)
Part 1a and 1b: Percentage of AUCinf that is extrapolated beyond the time of the last quantifiable concentration [%AUC (extrap)]
Part 1a and 1b: Terminal elimination rate constant (λz)
Part 1a and 1b: Time to achieve Cmax (tmax)
Day 180
Part 2: Sparse plasma PK blood sampling for population PK analysis
Day 7
Part 1a and 1b: AUC normalized to dose administered at steady state (AUCss_D)
Part 1a and 1b: AUC(0-t) at steady state [AUC(0-t_ss)]
Part 1a and 1b: AUCtau at steady state [AUC(tau_ss)]
Part 1a and 1b: Accumulation ratio calculated using AUC [Rac (AUC)]
Part 1a and 1b: Accumulation ratio calculated using Cmax [Rac (Cmax)]
Part 1a and 1b: Apparent oral clearance at steady state (CL/Fss)
Part 1a and 1b: Average observed concentration at steady state (Cav,ss)
Part 1a and 1b: Cmax at steady state (Cmax,ss)
Part 1a and 1b: Cmax_ss normalized to dose administered (Cmaxss_D)
Part 1a and 1b: Ctrough at steady state (Ctrough_ss)
Part 1a and 1b: Fraction of dose excreted in urine (Fe)
Part 1a and 1b: Minimum concentration at steady state (Cmin,ss)
Part 1a and 1b: Renal clearance (CLR)
Part 1a and 1b: tmax at steady state (tmax,ss)
Day 730
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
Day 730
Part 1a,1b and 2: Number of participants with adverse events and serious adverse events
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Trial Design
8 Treatment Groups
Part 1a: Cohort 1.1a Dose 400 mg
1 of 8
Part 1b: Cohort 1.1b Dose 200 mg
1 of 8
Part 1b: Cohort 1.3b Dose 600 mg
1 of 8
Part 2: Cohort 2.2 Dose Y
1 of 8
Part 2: Cohort 2.1 Dose X
1 of 8
Part 1a: Cohort 1.2a Dose 600 mg
1 of 8
Part 1b: Cohort 1.2b Dose 400 mg
1 of 8
Part 1a: Cohort 1.3a Dose 800 mg
1 of 8
Experimental Treatment
330 Total Participants · 8 Treatment Groups
Primary Treatment: Part 1a: Cohort 1.1a Dose 400 mg · Has Placebo Group · Phase 2
Part 1a: Cohort 1.1a Dose 400 mgExperimental Group · 2 Interventions: KM-819, Placebo · Intervention Types: Drug, Drug
Part 1b: Cohort 1.1b Dose 200 mgExperimental Group · 2 Interventions: KM-819, Placebo · Intervention Types: Drug, Drug
Part 1b: Cohort 1.3b Dose 600 mgExperimental Group · 2 Interventions: KM-819, Placebo · Intervention Types: Drug, Drug
Part 2: Cohort 2.2 Dose YExperimental Group · 2 Interventions: KM-819, Placebo · Intervention Types: Drug, Drug
Part 2: Cohort 2.1 Dose XExperimental Group · 2 Interventions: KM-819, Placebo · Intervention Types: Drug, Drug
Part 1a: Cohort 1.2a Dose 600 mgExperimental Group · 2 Interventions: KM-819, Placebo · Intervention Types: Drug, Drug
Part 1b: Cohort 1.2b Dose 400 mgExperimental Group · 2 Interventions: KM-819, Placebo · Intervention Types: Drug, Drug
Part 1a: Cohort 1.3a Dose 800 mgExperimental Group · 2 Interventions: KM-819, Placebo · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
KM-819
2016
Completed Phase 1
~90
Placebo
1995
Completed Phase 3
~2670
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 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
Who is running the clinical trial?
FAScinate Therapeutics Inc.Lead Sponsor
ParexelIndustry Sponsor
275 Previous Clinical Trials
95,557 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 7 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Female participants who are neither pregnant nor breastfeeding may be eligible to participate.
You are either a healthy volunteer or have been clinically diagnosed with idiopathic Parkinson's disease.
You have been taking a consistent medication regimen for at least two months to manage Parkinson's Disease.
You have an idiopathic Parkinson's disease diagnosis with a Hoehn and Yahr Stage of four or lower.
You have not taken dopamine/dopaminergic drugs, levodopa with decarboxylase inhibitor or dopaminergic agonists for at least 30 days prior to Screening.
Your Body Mass Index (BMI) is between 18.5 and 35 kilograms per square metre, encompassing the typical range for healthy adults.
Male participants must not be cohabiting with a pregnant or breastfeeding partner, and must commit to using an efficacious form of contraception from the Screening stage onwards, whilst abstaining from sperm donation.
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Conditions
Cancer Related
Treatments