Multiple Ascending Dose Study of PRX002 in Patients With Parkinson's Disease

Study Overview
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Brief Summary
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This multiple ascending dose study is to determine safety, tolerability, pharmacokinetics and immunogenicity of PRX002 in approximately 60 patients with Parkinson's disease.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of PRX002 Administered By Intravenous Infusion in Patients With Parkinson's Disease

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Drug: PRX002
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Idiopathic Parkinson's disease, Hoehn and Yahr 1-3 Body weight range of ≥ 45kg/99 lbs to ≤ 110 kg/242 lbs Female subjects must be surgically sterile or post-menopausal or if of child-bearing potential must use contraception Male subjects and their partners of childbearing potential must use contraception Exclusion Criteria: Significant cardiac history Abnormal MRI Significant laboratory abnormalities

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRX002<br>PRX002 | Drug: PRX002<br> <br> |
| Placebo Comparator: Placebo<br>Placebo | Other: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability as determined by number of subjects with adverse events |  | up to 6 months | 
| Determination of pharmacokinetics parameters | maximum concentration (Cmax) | up to 6 months | 
| Determination of pharmacokinetics parameters | time of the maximum measured concentration (Tmax) | 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) | up to 6 months | 
| Determination of pharmacokinetics parameters | area under the concentration-time curve from time zero extrapolated to infinity (AUCinf) | up to 6 months | 
| Determination of pharmacokinetics parameters | elimination rate constant | up to 6 months | 
| Determination of pharmacokinetics parameters | terminal elimination half life (t½) | up to 6 months | 
| Determination of pharmacokinetics parameters | clearance (CL) | up to 6 months | 
| Determination of pharmacokinetics parameters | apparent volume of distribution (Vd) | up to 6 months | 
| Determination of pharmacokinetics parameters | average concentration over a dosing interval (Cav) | up to 6 months | 
| Determination of pharmacokinetics parameters | area under the plasma concentration-time curve for a dosing interval (AUCtau) | up to 6 months | 
| Determination of pharmacokinetics parameters | minimum observed concentration (Cmin) | up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity as determined by measurement of anti-PRX002 antibodies | Multiple clinical and exploratory biomarkers will be assessed | up to 3 months |