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This single ascending dose study is to determine safety, tolerability, pharmacokinetics and immunogenicity of PRX003 in approximately 40 healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRX003 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRX003 | 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-(Cmax) | maximum concentration (Cmax) | Up to 3 months |
| Determination of pharmacokinetics parameters-(AUClast) | 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-(AUCinf) | area under the concentration-time curve from time zero extrapolated to infinity (AUCinf) | Up to 3 months |
| Determination of pharmacokinetics parameters-elimination rate constant | elimination rate constant | Up to 3 months |
| Determination of pharmacokinetics parameters-(t½) | terminal elimination half life (t½) | Up to 3 months |
| Determination of pharmacokinetics parameters-(CL) | clearance (CL) | Up to 3 months |
| Determination of pharmacokinetics parameters-(Vd) | apparent volume of distribution (Vd) | Up to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity as determined by measurement of anti-PRX003 antibodies | Up to 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Worldwide Clinical Trials Early Phase Services | San Antonio | Texas | United States |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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