drugset
drugset / Trial / NCT04072237

Study of Coagulation Faction VIIa Variant Marzeptacog Alfa (Activated) in Adult Subjects With Hemophilia

NCT04072237 ↗

Phase 1 Completed 11 enrolled Catalyst Biosciences
NaSequentialOpen-labelDiagnostic

Summary

This multi-center, open label Phase 1 study will evaluate the pharmacokinetics, pharmacodynamics, and safety of a single IV dose of MarzAA followed by ascending single SC doses of MarzAA in adult subjects with moderate or severe Hemophilia A or B, with or without an inhibitor.

Timeline

Start
2019-09-24
Primary completion
2020-04-30
Completion
2020-06-17

Drugs

EvaluationDrugModalityDoseRoute
Subject MarzAA Protein / enzyme biologic 18 ug/kg Intravenous
Subject MarzAA Protein / enzyme biologic 30 ug/kg Intravenous
Subject MarzAA Protein / enzyme biologic 45 ug/kg Intravenous
Subject MarzAA Protein / enzyme biologic 60 ug/kg Intravenous
Subject MarzAA Protein / enzyme biologic 90 ug/kg Intravenous
Subject MarzAA Protein / enzyme biologic 120 ug/kg Intravenous
Subject MarzAA Protein / enzyme biologic 180 ug/kg Intravenous

Indications

hemophilia A hemophilia B