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drugset / Trial / NCT02914353

Study to Evaluate Safety, PK and PD of Single and Multiple Ascending Doses of EP-7041 in Healthy Subjects

NCT02914353 ↗

Phase 1 Completed 80 enrolled eXIthera Pharmaceuticals CPR Pharma Services Pty Ltd, Australia · collabIDT CMAX Clinical Trials · collabSyneos Health · collab
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This First-In-Human study will evaluate the safety and tolerability, pharmacokinetic profile, and pharmacodynamic effects of EP-7041, a novel Factor XIa inhibitor, following IV administration of single ascending doses in healthy normal volunteers, and following continuous IV infusions of multiple ascending doses in healthy normal volunteers.

Timeline

Start
2016-07
Primary completion
2017-05
Completion
2017-05

Drugs

EvaluationDrugModalityDoseRoute
Subject FRUNEXIAN Small molecule 0.01 mg/kg Intravenous
Subject FRUNEXIAN Small molecule 0.6 mg/kg Intravenous
Subject FRUNEXIAN Small molecule 1 mg/kg Intravenous

Indications

osteoarthritis, knee