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XBiotech 8201 E Riverside Dr 78744 TX Austin http://www.xbiotech.com/
Contact Ms Ashley Otero +1 512-386-2930
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XBiotech

XBiotech schließt Dosisvergabe an Probanden der PK-Studie, die in Verbindung mit dem europäischen Zulassungsantrag durchgeführt wird, ab

(PresseBox) (Austin, Texas, )
XBiotech Inc. (NASDAQ:XBIT) gab bekannt, dass die Dosisvergabe an die Teilnehmer seiner pharmakokinetischen (PK) Studie zur Untersuchung der Halbwertszeit von MABp1 an freiwilligen gesunden Probanden abgeschlossen ist. Die Phase-I-Studie wird weitere PK-Daten liefern und ermöglicht die zusätzliche Charakterisierung der Pharmakokinetik von MABp1 bei einer intravenös injizierten Dosis von 7,5 mg/kg. Sicherheit und Verträglichkeit werden ebenfalls untersucht. Die Durchführung der PK-Analysen und die Erhebung der Daten erfolgt zu verschiedenen Zeitpunkten, z. B. vor der Infusion und 336 Stunden nach der Infusion. Die Studie verläuft planmäßig, sodass sie wie vorgesehen bis zur anstehenden Zulassungseinreichung abgeschlossen sein wird.

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