A COVID-19 Study to Evaluate Safety and Pharmacokinetics of COVID-HIGIV Administered in Healthy Adults

Summary

This study is designed to evaluate three dose levels of Anti-SARS-CoV-2 Immunoglobulin Intravenous (Human) (COVID-HIGIV) for safety and pharmacokinetics (PK) in healthy adults. Twenty-eight healthy adult subjects will be enrolled into the study to receive a single dose of COVID-HIGIV or placebo with 84 days of safety and PK follow-up post-administration.

Timeline

Start

2020-12-24

Primary completion

2021-07-27

Completion

2021-07-27

Publications

• Liu STH, Mirceta M, Lin G, Anderson DM, Broomes T, Jen A, Abid A, Reich D, Hall C, Aberg JA. 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. Antimicrob Agents Chemother. 2023 Mar 16;67(3):e0151422. doi: 10.1128/aac.01514-22. Epub 2023 Feb 28.

Drugs

Indications