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

Phase 1 Unknown 21 enrolled SAb Biotherapeutics, Inc. Biomedical Advanced Research and Development Authority · collab Joint Program Executive Office (JPEO) Chemical, Biological, Radiological, and Nuclear Defense (CBRND) Enabling Biotechnologies (EB) · collab

RandomizedSequentialQuadruple-blindTreatment

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.

Timeline

Start: 2020-08-20
Primary completion: 2021-02-25
Completion: 2021-11

Publications

Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	SAB-185	Protein / enzyme biologic	10 mg/kg	Intravenous
Subject	SAB-185	Protein / enzyme biologic	25 mg/kg	Intravenous
Subject	SAB-185	Protein / enzyme biologic	50 mg/kg	Intravenous

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

Summary

Timeline

Publications

Drugs

Indications