Study of SAB-176 in Healthy Adult Participants

Influenza A H1N1 Clinical Trial

Official title:
A Phase 2a, Randomised, Double-blind, Placebo-controlled Study to Evaluate the Safety and Treatment Efficacy of SAB-176 (a Quadrivalent Anti-seasonal Influenza Immunoglobulin Product) in an H1N1 Challenge Model in Healthy Adult Participants

Status Active, not recruiting

Clinical Trial Summary

Healthy adult participants will be challenged with the H1N1 Influenza virus and then treated with either SAB-176 or placebo.

Clinical Trial Description

Up to 60 eligible participants will be randomized in a 1:1 ratio to receive either SAB-176 (up to 25 mg/kg dose) or placebo. Healthy adult participants will be pre-screened for serosuitability for Influenza A/California/2009 H1N1 challenge virus. Serosuitable participants who sign the study specific informed consent form (ICF) will be challenged with an intranasal administration of Influenza A/California/2009 H1N1 virus on Day 0. Participants will be given intravenous (IV) infusion of SAB-176 or placebo on Day 1. Participants will be held in quarantine until Day 8. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04850898
Study type	Interventional
Source	SAb Biotherapeutics, Inc.
Contact
Status	Active, not recruiting
Phase	Phase 2
Start date	June 23, 2021
Completion date	December 2021

View Details

See also
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