NCT04469179

Safety, Tolerability, and Pharmacokinetics of SAB-185 in Ambulatory Participants With COVID-19

A Phase 1B, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of SAB-185 in Ambulatory Subjects With COVID-19

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: SAb Biotherapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not 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 ambulatory participants with COVID-19.

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: 2020-08-20
• Primary completion: 2021-02-25
• Completion: 2021-11-01
• First posted: 2020-07-13
• Last updated: 2021-10-26

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study