drugset / Trial / NCT04471038

Safety, Tolerability, and Pharmacokinetics of SAB-176 in Healthy Participants

NCT04471038 ↗

Phase 1 Completed 27 enrolled SAb Biotherapeutics, Inc.
RandomizedSequentialQuadruple-blindTreatment

Summary

Influenza causes substantial morbidity and mortality worldwide despite available antivirals and vaccines. SAB Biotherapeutics, Inc. has developed SAB-176, an anti-influenza human immunoglobulin (transchromosomic \[Tc\] bovine-derived) intravenous therapeutic to treat past and current strains of Type A Influenza and Type B Influenza. This study will evaluate the safety, tolerability, and pharmacokinetics of SAB-176 in healthy participants.

Timeline

Start
2020-07-29
Primary completion
2021-04-19
Completion
2021-04-19

Drugs

EvaluationDrugModalityDoseRoute
Subject SAB-176 Protein / enzyme biologic 1 mg/ml Intravenous
Subject SAB-176 Protein / enzyme biologic 10 mg/kg Intravenous
Subject SAB-176 Protein / enzyme biologic 25 mg/kg Intravenous
Subject SAB-176 Protein / enzyme biologic 50 mg/kg Intravenous

Indications