NCT04468958

Safety, Tolerability, and Pharmacokinetics of SAB-185 in Healthy Participants

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study of SAB-185 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: SAb Biotherapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• COVID-19
• SARS-CoV2

Interventions

Type	Name	Description
BIOLOGICAL	SAB-185	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.
OTHER	Normal saline	Normal (0.9%) saline in approximately the same volume as each cohort in the experimental drug arm.

Timeline

• Start date: 2020-07-01
• Primary completion: 2020-12-23
• Completion: 2020-12-23
• First posted: 2020-07-13
• Last updated: 2022-07-01

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study