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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02788188 | Safety, Tolerability, and Pharmacokinetics of SAB-301 in Healthy Adults | PHASE1 | COMPLETED | 38 | — | — | May 28, 2016 | Apr 30, 2018 | Jun 12, 2018 | 1 | United States |
Number of participants who experienced an adverse event
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | Cohort 1: 1mg/kg SAB-301 in normal (9%) saline; concentration 1mg/mL (0.1%) |
| Placebo | PLACEBO_COMPARATOR | Normal (0.9%) saline in approximately the same volume as each cohort in the experimental drug arm. |
| Cohort 2 | EXPERIMENTAL | Cohort 2: 2.5 mg/kg SAB-301 in normal (9%) saline; concentration 1mg/mL (0.1%) |
| Cohort 3 | EXPERIMENTAL | Cohort 3: 5mg/kg SAB-301 in normal (9%) saline; concentration 4mg/mL (0.4%) |
| Cohort 4 | EXPERIMENTAL | Cohort 4: 10mg/kg SAB-301 in normal (9%) saline; concentration 4mg/mL (0.4%) |
| Cohort 5 | EXPERIMENTAL | Cohort 5: 20mg/kg SAB-301 in normal (9%) saline; concentration 20mg/mL (2%) |
| Cohort 6 | EXPERIMENTAL | Cohort 6: 50mg/kg SAB-301 in normal (9%) saline; concentration 20mg/mL (2%) |
| Name | Type | Description |
|---|---|---|
| SAB-301 | BIOLOGICAL | SAB-301 is a purified human immune globulin G (hIgG) polyclonal antibody designed to specifically bind to the MERS-CoV spike (S) protein, a component of the virion membrane that is responsible for binding of the virus to the host cell. The hIgG is purified from the plasma of immunized transchromosomic (Tc) bovines that were immunized with a recombinant spike protein produced in insect cells. SAB-301 is purified hIgG in 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 (9%) Saline | OTHER | Normal (0.9%) saline in approximately the same volume as each cohort in the experimental drug arm. |
* INCLUSION CRITERIA: 1. Age greater than or equal to 18 years and less than or equal to 60 years 2. Body mass index (BMI) of 19-32 kg/m(2) 3. Estimated glomerular filtration rate greater than or equal to 70 mL/min at screening, calculated using the CKD-EPI formula 4. Subjects must agree to...