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

NCT03624946 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-03-18

Study results available
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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.

Conditions

  • Zika Virus Infection
  • Zika Virus Disease

Interventions

BIOLOGICAL

Zika Virus Immune Globulin (ZIKV-IG)

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

OTHER

Placebo

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

Sponsors & Collaborators

  • Emergent BioSolutions

    lead INDUSTRY

Principal Investigators

  • Vadim Dreyzin, MD · Syneos Health

  • Michael McDonnell, MD · Syneos Health

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-06-27
Primary Completion
2019-03-06
Completion
2019-03-06
FDA Drug
Yes

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03624946 on ClinicalTrials.gov