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The purpose of this study is to assess the safety and tolerability of PRX019 in healthy adult participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRX019, single dose | Experimental | Specified dose on specified days |
|
| PRX019, multiple dose | Experimental | Specified dose on specified days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRX019 | Drug | Specified dose on specified days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | Up to 6 months | |
| Number of participants with clinical laboratory assessment abnormalities | Up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) | Up to 6 months | |
| Time to the maximum measured plasma concentration (Tmax) | Up to 6 months | |
| Area under the concentration-time curve from time 0 through the intended dosing interval (AUCͳ) |
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Inclusion Criteria:
Exclusion Criteria:
NOTE: Other protocol-defined inclusion/exclusion criteria apply
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| Name | Affiliation | Role |
|---|---|---|
| Chad Swanson | Prothena Biosciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Los Alamitos | California | 90720 | United States |
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| Placebo |
| Drug |
Placebo |
|
| Up to 6 months |
| Terminal elimination half-life in plasma (t1/2) | Up to 6 months |
| Maximum observed plasma concentration at steady state (Cmax,ss) | Up to 6 months |
| Area under the concentration-time curve from time 0 through the intended dosing interval at steady state (AUCͳ,ss) | Up to 6 months |