drugset / Trial / NCT04468958
Safety, Tolerability, and Pharmacokinetics of SAB-185 in Healthy Participants
Phase 1
Completed
28 enrolled
SAb Biotherapeutics, Inc.
Department of Health and Human Services · collabJPEO, 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 healthy participants.
Timeline
- Start
- 2020-07-01
- Primary completion
- 2020-12-23
- Completion
- 2020-12-23
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 |