Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SAB-185 · 1 trial · 2 indications
Incidence and severity of other adverse events and severe adverse events (SAE)
transfusion-related adverse events
| Arm | Type | Description |
|---|---|---|
| 10mg/kg SAB-185 | EXPERIMENTAL | 10mg/kg SAB-185 in normal (0.9%) saline; concentration 4mg/mL (0.4%) |
| 25mg/kg SAB-185 | EXPERIMENTAL | 25mg/kg SAB-185 in normal (0.9%) saline; concentration 20mg/mL (2%) |
| 25mg/kg SAB-185 x 2 doses | EXPERIMENTAL | 25mg/kg SAB-185 in normal (0.9%) saline; concentration 20mg/mL (2%). Cohort 3 will receive a second 25mg/kg dose of SAB-185 7 days (+/-2) after the first treatment. |
| 50mg/kg SAB-185 | EXPERIMENTAL | 50mg/kg SAB-185 in normal (0.9%) saline; concentration 20mg/mL (2%) |
| Placebo | PLACEBO_COMPARATOR | Normal (0.9%) saline in approximately the same volume as each cohort in the experimental drug arm. |
| Name | Type | Description |
|---|---|---|
| SAB-185 | BIOLOGICAL | 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. |
| Normal saline | OTHER | Normal (0.9%) saline in approximately the same volume as each cohort in the experimental drug arm. |
Inclusion Criteria: Subjects must meet all of the following criteria for inclusion: 1. 18-60 years of age 2. Able to understand the study and comply with all study procedures 3. Agrees not to participate in any other trial of an investigational product during the study period 4. Willing and able t...
SAB-185 is an investigational monoclonal antibody being developed for COVID-19. It is currently in Phase 1 clinical development, meaning it has not been approved for any use. The drug is being studied for its safety, tolerability, and pharmacokinetics in healthy participants.
SAB-185 is a monoclonal antibody, a type of protein designed to bind to a specific target. However, its specific molecular target has not been disclosed. The drug is being evaluated for its potential to address COVID-19, though its mechanism of action is not publicly detailed.
SAB-185 is being developed by SAB Biotherapeutics, Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol SABS. SAB Biotherapeutics is responsible for the clinical development of this investigational drug.
SAB-185 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug remains in early-stage clinical testing.
SAB-185 has one completed clinical trial, identified as NCT04468958. This Phase 1 study, titled 'Safety, Tolerability, and Pharmacokinetics of SAB-185 in Healthy Participants,' enrolled 28 participants in the United States. The trial was randomized, double-blind, and placebo-controlled.
No alternative names for SAB-185 have been disclosed. The drug is known only by its code name SAB-185 in clinical and regulatory contexts. It is a distinct investigational monoclonal antibody being developed by SAB Biotherapeutics.