At a glance

ClinicalIndex Comparison Record

Phase 1Completed· 30 enrolled

Drug / intervention

Zika Virus Immune Globulin (ZIKV-IG) +1 morebiological

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03624946

NCT03624946Phase 1Completed

Compare CT.gov

Safety and Pharmacokinetic Evaluation of Zika Virus Immune Globulin in Healthy Volunteers

Emergent BioSolutions·interventional·Posted Aug 10, 2018·Updated Mar 18, 2024

In Brief

A Phase 1 clinical trial evaluating Zika Virus Immune Globulin (ZIKV-IG) and Placebo for Zika Virus Infection and Zika Virus Disease. Completed, enrolled 30 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsZika Virus Infection, Zika Virus Disease

CountriesCanada

Collaborators--

Timeline

Phase 1CompletedFinished

20192020202120222023202420252026

Enrollment StartJun 2018

First PostedAug 2018

Primary CompletionMar 2019

TodayJul 2026

First PostedAug 10, 2018

Enrollment StartJun 27, 2018

Primary CompletionMar 6, 2019

TodayJul 2, 2026

Enrollment to primary: 8 monthsPosted 7.9 years ago

Interventions

Zika Virus Immune Globulin (ZIKV-IG)biological

Zika Virus Immune Globulin (ZIKV-IG) is a human immune globulin preparation containing neutralizing antibodies to Zika virus.

Placeboother

Placebo is a normal saline solution (0.9% sodium chloride).