NCT04468958

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

Completed Phase 1 Last updated 1 July 2022

What this trial tests

Phase 1 trial testing SAB-185 in COVID-19 in 28 participants. Completed in 23 December 2020.

Timeline

1 July 2020

Primary endpoint
23 December 2020

23 December 2020

Quick facts

Lead sponsor	SAb Biotherapeutics, Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	quadruple
Primary purpose	treatment
Enrollment	28
Start date	1 July 2020
Primary completion	23 December 2020
Estimated completion	23 December 2020
Sites	3 locations across United States

Drugs / interventions tested

• SAB-185 — full drug profile →
• Normal saline

Conditions studied

• COVID-19 — all drugs for COVID-19 →
• SARS-CoV2 — all drugs for SARS-CoV2 →

Sponsor

SAb Biotherapeutics, Inc. — full company profile →

Who can join

Adults 18 to 60, any sex, with COVID-19 or SARS-CoV2. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review.
   Piechotta V, Iannizzi C, Chai KL, Valk SJ, et al · · 2021 · cited 106× · PMID 34013969 · DOI 10.1002/14651858.cd013600.pub4
2. Neutralizing antibodies against SARS-CoV-2: current understanding, challenge and perspective.
   Huang Y, Sun H, Yu H, Li S, et al · · 2020 · cited 36× · PMID 33912797 · DOI 10.1093/abt/tbaa028
3. Passive Immunotherapy Against SARS-CoV-2: From Plasma-Based Therapy to Single Potent Antibodies in the Race to Stay Ahead of the Variants.
   Strohl WR, Ku Z, An Z, Carroll SF, et al · · 2022 · cited 31× · PMID 35476216 · DOI 10.1007/s40259-022-00529-7
4. Convalescent plasma for people with COVID-19: a living systematic review.
   Iannizzi C, Chai KL, Piechotta V, Valk SJ, et al · · 2023 · cited 24× · PMID 36734509 · DOI 10.1002/14651858.cd013600.pub5
5. Recent advances in antibody-based immunotherapy strategies for COVID-19.
   Esmaeilzadeh A, Rostami S, Yeganeh PM, Tahmasebi S, et al · · 2021 · cited 24× · PMID 34160093 · DOI 10.1002/jcb.30017
6. Convalescent plasma for people with COVID-19: a living systematic review.
   Iannizzi C, Chai KL, Piechotta V, Valk SJ, et al · · 2023 · cited 21× · PMID 37162745 · DOI 10.1002/14651858.cd013600.pub6
7. Therapeutic antibodies for COVID-19: is a new age of IgM, IgA and bispecific antibodies coming?
   Zhang J, Zhang H, Sun L. · · 2022 · cited 21× · PMID 35220888 · DOI 10.1080/19420862.2022.2031483
8. Human immunoglobulin from transchromosomic bovines hyperimmunized with SARS-CoV-2 spike antigen efficiently neutralizes viral variants.
   Liu Z, Wu H, Egland KA, Gilliland TC, et al · · 2022 · cited 21× · PMID 34228597 · DOI 10.1080/21645515.2021.1940652