Trial design.
This study was a phase 1, single-center, randomized, double-blind, placebo-controlled design to assess the safety and PK of COVID-HIGIV in healthy adults. Eligible participants were randomized in a ratio of 2:2:2:1 to one of four study treatment arms to receive a single intravenous (IV) infusion of one of three COVID-HIGIV dose levels (arms 1 to 3) or saline placebo (arm 4), respectively. Assessment and sampling time points included predose (baseline) and postdose at 1 h, 2 h, 4 h, 8 h, 12 h, day 2, day 4, day 8, day 15, day 22, day 29, day 43, day 57, and day 85 or at the withdrawal visit.Noteworthy protocol modifications were made in each protocol amendment. Importantly, urine drug screening and a history of elective surgery were removed from exclusion criteria as they would not definitively lead to protocol noncompliance. Guidelines pertaining to COVID-19 vaccination during study conduct were revised so that those who received placebo could receive the COVID-19 vaccine.