This will be a Phase 1, two-center, open-label, randomized study to evaluate one dose level of COVID-HIG administered IM or SC for safety and PK in healthy adults compared to COVID-HIG administered intravenously. Approximately 36 adult participants will be targeted to be enrolled in the study. Enrollment into the study will be staggered, wherein no more than three participants will be randomized and dosed on the first day with at least one hour between dosing of each participant. On the second day, up to two more subjects will be randomized and dosed. The remaining participants will be randomized and dosed, with no more than 5 participants dosed per day. Safety data will be reviewed by a Safety Monitoring Committee (SMC) (consisting of at least three independent external members) after all 12 participants in Cohort 1 have completed at least 72 hours of safety follow-up. An overall decision by the SMC will be made whether to proceed with full randomization (1:1:1) and dosing of the remaining study participants (Cohort 2, n=24). Participants will be stratified based on their SARS-CoV-2 antibody status (positive/negative) at screening.~Study enrollment and administration of study treatments may be paused by the PI or medical monitor for safety review by the SMC if any of the following occur after study product administration and during the enrollment period:~One or more serious adverse event(s) [SAE(s)].~Three or more of the same Grade 3 adverse events (AEs)~Three or more Grade 2 hypersensitivity AEs~If any participants become positive for SARS-CoV-2 during the study follow-up period, they will be assessed using an Ordinal Outcome Scale until symptom resolution and will be followed until they complete their last scheduled follow-up visit. Participants who test positive for SARS-CoV-2 will be excluded from PK analyses.
It is hypothesized that COVID-HIG in all three routes of administration (intramuscular [IM], subcutaneous [SC], and intravenous [IV]) is well-tolerated and that concentrations of SARS-CoV-2 antibodies will be measurable over time, with derived pharmacokinetic (PK) parameters in line with immunoglobulin product class kinetics.