Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Single Ascending Dose of SAB-176
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...
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SAB-176 is an investigational monoclonal antibody developed by SAB Biotherapeutics, Inc. (ticker: SABS) for the treatment of influenza. It is being studied in Influenza A H1N1 and Influenza Type A. The drug has received FAST_TRACK and BREAKTHROUGH_THERAPY designations from the FDA.
SAB-176 is being developed for Influenza A H1N1 and Influenza Type A. It is an investigational monoclonal antibody intended for use in infectious disease. The clinical program has studied the drug in healthy adult participants, and it has not been approved for any indication.
SAB-176 is developed by SAB Biotherapeutics, Inc., which trades under the ticker SABS. The company is the sponsor of the clinical trials evaluating the drug in influenza indications.
SAB-176 is in Phase 2 development. One Phase 2 trial has been completed, and a Phase 1 trial has also been completed. The drug is investigational and has not been approved by the FDA for any indication.
SAB-176 has been evaluated in two completed clinical trials. NCT04850898 was a Phase 2 study of SAB-176 in healthy adult participants in the United Kingdom, enrolling 62 participants. NCT04471038 was a Phase 1 safety, tolerability, and pharmacokinetics study in healthy participants in the United States, enrolling 27 participants.
SAB-176 is not approved by the FDA. It is an investigational monoclonal antibody in Phase 2 clinical development for Influenza A H1N1 and Influenza Type A. The FDA has granted SAB-176 FAST_TRACK and BREAKTHROUGH_THERAPY designations.