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| Name | Class |
|---|---|
| Hoffmann-La Roche | INDUSTRY |
This single ascending dose study is to determine safety, tolerability, pharmacokinetics and immunogenicity of PRX002 in approximately 40 healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRX002 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRX002 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability as determined by number of subjects with adverse events | up to 3 months | |
| Determination of pharmacokinetics parameters | - maximum concentration (Cmax) | up to 3 months |
| Determination of pharmacokinetics parameters | - time of the maximum measured concentration (Tmax) | up to 3 months |
| Determination of pharmacokinetics parameters | - area under the concentration-time curve from time zero to the last quantifiable concentration time-point (AUClast) | up to 3 months |
| Determination of pharmacokinetics parameters | - area under the concentration-time curve from time zero extrapolated to infinity (AUCinf) | up to 3 months |
| Determination of pharmacokinetics parameters | - elimination rate constant | up to 3 months |
| Determination of pharmacokinetics parameters | - terminal elimination half life (t½) | up to 3 months |
| Determination of pharmacokinetics parameters | - clearance (CL) | up to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity as determined by measurement of anti-PRX002 antibodies | up to 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Theresa Neumann, PhD | Clinical Trials Prothena Biosciences Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Antonio | Texas | United States |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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|
| Determination of pharmacokinetics parameters | - apparent volume of distribution (Vd) | up to 3 months |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |