drugset / Trial / NCT03624946

Study in Healthy Volunteers Evaluating Safety and Pharmacokinetics of Zika Virus Immune Globulin (ZIKV-IG)

NCT03624946 ↗

Phase 1 Completed 30 enrolled Emergent BioSolutions
RandomizedParallel-groupQuadruple-blindPrevention

Summary

Currently, there are no licensed therapeutics against Zika virus infection. Due to this unmet medical need, Zika Virus Immune Globulin (ZIKV-IG) is being developed as a therapeutic intervention against Zika virus infection. In this first-in-human study, evaluation of ZIKV-IG safety and pharmacokinetics (absorption, metabolism and excretion) will be conducted in healthy adult volunteers.

Timeline

Start
2018-06-27
Primary completion
2019-03-06
Completion
2019-03-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Zika Virus Immune Globulin (ZIKV-IG) Protein / enzyme biologic 50 ml Intravenous