Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04468958 | Safety, Tolerability, and Pharmacokinetics of SAB-185 in Healthy Participants | PHASE1 | COMPLETED | 28 | — | — | Jul 1, 2020 | Dec 23, 2020 | Jul 1, 2022 | 3 | United States |
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...