drugset
drugset / Trial / NCT01731275

A Phase 1 Single Dose Study of E6011 in Japanese Healthy Adult Male Subjects (Study E6011-J081-001)

NCT01731275 ↗

Phase 1 Completed 64 enrolled Eisai Inc.
RandomizedParallel-groupDouble-blindTreatment

Summary

To evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of a single ascending dose (SAD) administration of E6011 in Japanese healthy volunteers.

Timeline

Start
2012-08
Primary completion
2013-08
Completion
2013-08

Drugs

EvaluationDrugModalityDoseRoute
Subject QUETMOLIMAB Monoclonal antibody 0.0006 mg/kg Intravenous
Subject QUETMOLIMAB Monoclonal antibody 0.006 mg/kg Intravenous
Subject QUETMOLIMAB Monoclonal antibody 0.04 mg/kg Intravenous
Subject QUETMOLIMAB Monoclonal antibody 0.2 mg/kg Intravenous
Subject QUETMOLIMAB Monoclonal antibody 1 mg/kg Intravenous
Subject QUETMOLIMAB Monoclonal antibody 3 mg/kg Intravenous
Subject QUETMOLIMAB Monoclonal antibody 6 mg/kg Intravenous
Subject QUETMOLIMAB Monoclonal antibody 10 mg/kg Intravenous

Indications

No indication recorded.