This multiple ascending dose study is to determine safety, tolerability, pharmacokinetics and immunogenicity of PRX002 in approximately 60 patients with Parkinson's disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
64
Collaborative Neuroscience Network, LLC
Long Beach, California, United States
Institute for Neurodegenerative Disorders
New Haven, Connecticut, United States
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, United States
MD Clinical
Safety and tolerability as determined by number of subjects with adverse events
Time frame: up to 6 months
Determination of pharmacokinetics parameters
maximum concentration (Cmax)
Time frame: up to 6 months
Determination of pharmacokinetics parameters
time of the maximum measured concentration (Tmax)
Time frame: up to 6 months
Determination of pharmacokinetics parameters
area under the concentration-time curve from time zero to the last quantifiable concentration time-point (AUClast)
Time frame: up to 6 months
Determination of pharmacokinetics parameters
area under the concentration-time curve from time zero extrapolated to infinity (AUCinf)
Time frame: up to 6 months
Determination of pharmacokinetics parameters
elimination rate constant
Time frame: up to 6 months
Determination of pharmacokinetics parameters
terminal elimination half life (t½)
Time frame: up to 6 months
Determination of pharmacokinetics parameters
clearance (CL)
Time frame: up to 6 months
Determination of pharmacokinetics parameters
apparent volume of distribution (Vd)
Time frame: up to 6 months
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Hallandale, Florida, United States
Compass Research, LLC
Orlando, Florida, United States
QUEST Research Institute
Bingham Farms, Michigan, United States
Oregon Health and Science University, Department of Neurology
Portland, Oregon, United States
Baylor College of Medicine
Houston, Texas, United States
Determination of pharmacokinetics parameters
average concentration over a dosing interval (Cav)
Time frame: up to 6 months
Determination of pharmacokinetics parameters
area under the plasma concentration-time curve for a dosing interval (AUCtau)
Time frame: up to 6 months
Determination of pharmacokinetics parameters
minimum observed concentration (Cmin)
Time frame: up to 6 months
Immunogenicity as determined by measurement of anti-PRX002 antibodies
Multiple clinical and exploratory biomarkers will be assessed
Time frame: up to 3 months