Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SAB-176 · 2 trials · 4 indications
Area under the viral load-time curve (VL-AUC) of Influenza A/California/2009 H1N1 virus, as determined by Quantitative Reverse Transcriptase-Polymerase Chain Reaction (qRT-PCR) on nasal samples.
Incidence and severity of other adverse events and severe adverse events (SAE)
| Arm | Type | Description |
|---|---|---|
| Normal Saline Placebo Control | PLACEBO_COMPARATOR | Placebo control dosed 1 time via intravenous infusion |
| SAB-176 - 25mg/kg | EXPERIMENTAL | Investigational Medicinal Product dosed 1 time at 25 mg/kg on day 1 via intravenous infusion |
| Cohort 1 | EXPERIMENTAL | 1 mg/mL SAB-176 in normal (0.9%) Saline; concentration 1 mg/mL (0.1%) |
| Cohort 2 | EXPERIMENTAL | 10 mg/kgSAB-176 in normal (0.9%) Saline; concentration 4 mg/mL (0.4%) |
| Cohort 3 | EXPERIMENTAL | 25 mg/kgSAB-176 in normal (0.9%) Saline; concentration 20 mg/mL (2.0%) |
| Cohort 4 | EXPERIMENTAL | 50 mg/kg SAB-176 in normal (0.9%) Saline; concentration 20 mg/mL (2.0%) |
| Cohort 5 | PLACEBO_COMPARATOR | Normal (0.9%) saline in approximately the same volume as each cohort in the experimental drug arm. |
| Name | Type | Description |
|---|---|---|
| SAB-176 | BIOLOGICAL | Treatment of influenza |
| Placebo | OTHER | Placebo Control |
| Normal Saline | OTHER | Normal (0.9%) saline in approximately the same volume as each cohort in the experimental drug arm |
Inclusion Criteria: 1. An informed consent document signed and dated by the participant and the investigator 2. Aged between 18 and 45 years on the day of signing the study specific ICF. 3. In good health with no history, or current evidence, of clinically significant medical conditions, and no cli...
SAB-176 is an investigational monoclonal antibody being developed for influenza Type A and influenza A H1N1. It is being studied for use in infectious disease settings. The drug is currently in Phase 2 clinical development and has not been approved by the FDA.
SAB-176 is being developed by SAB Biotherapeutics, Inc., a biopharmaceutical company traded on the stock exchange under the ticker SABS. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational monoclonal antibody for influenza.
SAB-176 is currently in Phase 2 clinical development. It has completed a Phase 1 trial and a Phase 2 trial, both of which are finished. The drug is investigational and has not received FDA approval. It has been granted Fast Track and Breakthrough Therapy designations by the FDA.
SAB-176 has completed two clinical trials. The first was NCT04471038, a Phase 1 study in healthy participants in the United States. The second was NCT04850898, a Phase 2 study in healthy adults in the United Kingdom. Both trials are completed, and no active trials are currently listed.
SAB-176 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development. The FDA has granted it Fast Track and Breakthrough Therapy designations, which are intended to expedite the development and review of drugs for serious conditions.