Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). SAB Biotherapeutics has developed SAB-185, an Anti-SARS-CoV-2 Human Immunoglobulin Intravenous (transchromosomic \[Tc\] bovine-derived), as a potential therapeutic to treat COVID-19. This study will evaluate the safety, immunogenicity, and pharmacokinetics of SAB-185 in healthy participants.
There were 4 treatment groups and 1 control group. Cohort 1 received 1 dose of SAB-185 at 10 mg/kg per dose. Cohort 2 received 1 dose of SAB-185 at 25 mg/kg, Cohort 3 received 2 doses of SAB-185 at 25 mg/kg each 7 days apart, and Cohort 4 received 1 dose of SAB-185 at 50 mg/kg per dose. All the doses were prepared at the site by the pharmacy staff or designee for delivery to the clinical staff for administration, per the site's SOPs.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
28
SAB-185 is a purified human immunoglobulin G (hIgG) designed to specifically bind to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) viruses. SAB-185 is purified from the plasma of immunized Tc bovines that were immunized initially (vaccinations 1 and 2) with a plasmid DNA (pDNA) vaccine that expresses wild-type SARS-CoV-2 spike protein, followed by additional immunizations (vaccinations 3 and beyond) with a recombinant spike protein from SARS-CoV-2 produced in insect cells. The purified hIgG is a sterile liquid formulated in 10 mM glutamic acid monosodium salt, 262 mM D-sorbitol, 0.05 mg/mL Tween 80, pH 5.5. The drug product will be administered intravenously and will be diluted in saline per the clinical protocol.
Normal (0.9%) saline in approximately the same volume as each cohort in the experimental drug arm.
Alliance for Multispecialty Research, LLC
Wichita, Kansas, United States
SUNY Upstate Medical University
Syracuse, New York, United States
ICON Early Phase Services
San Antonio, Texas, United States
Number of Participants Having Adverse Events
Incidence and severity of other adverse events and severe adverse events (SAE)
Time frame: 29 Days
Number of Participants Having Transfusion-Related Adverse Events
transfusion-related adverse events
Time frame: 29 Days
Number of Participants Having Adverse Events
Incidence and severity of adverse events and SAEs from Screening through Study Day 90
Time frame: 90 Days
Pharmacokinetics from screening to day 90
SARS-CoV-2 binding (ELISA) and neutralizing (PRNT80) antibody titers from Screening through Study Day 90
Time frame: 90 Days
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