drugset / Trial / NCT01932437

Intramuscular Dose-Escalation Study With ETI-204 in Adult Volunteers

NCT01932437

Phase 1 Completed 36 enrolled Elusys Therapeutics
RandomizedSequentialTriple-blindOther

Summary

This study is to evaluate the safety, local tolerability, pharmacokinetics (PK) and immunogenicity of escalating single intramuscular (IM) doses of ETI-204 in healthy volunteers

Timeline

Start
2013-07-26
Primary completion
2014-07-03
Completion
2014-07-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Obiltoxaximab Monoclonal antibody 4 mg/kg Intramuscular
Subject Obiltoxaximab Monoclonal antibody 8 mg/kg Intramuscular
Subject Obiltoxaximab Monoclonal antibody 16 mg/kg Intramuscular
Subject Obiltoxaximab Monoclonal antibody 20 mg/kg Intramuscular
Subject Obiltoxaximab Monoclonal antibody 24 mg/kg Intramuscular

Indications