Safety, Tolerability, and Pharmacokinetics of Anti-SARS-CoV-2 Immunoglobulin Intravenous (Human) Investigational Product (COVID-HIGIV) in Healthy Adults: a Randomized, Controlled, Double-Blinded, Phase 1 Study

Author:

Liu Sean T. H.1ORCID,Mirceta Mila2,Lin Grace2,Anderson Deborah M.2,Broomes Tarashon1,Jen Alina1,Abid Ashley1,Reich David1,Hall Christine2,Aberg Judith A.1ORCID

Affiliation:

1. Division of Infectious Diseases, Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, New York, USA

2. Emergent BioSolutions Canada, Inc., Winnipeg, Manitoba, Canada

Abstract

Anti-SARS-CoV-2 immunoglobulin (human) investigational product (COVID-HIGIV) is a purified immunoglobulin preparation containing SARS-CoV-2 polyclonal antibodies. This single-center clinical trial aimed to characterize the safety and pharmacokinetics of COVID-HIGIV in healthy, adult volunteers.

Funder

U.S. Department of Defense

Publisher

American Society for Microbiology

Subject

Infectious Diseases,Pharmacology (medical),Pharmacology

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