NCT04850898

Study of SAB-176 in Healthy Adult Participants

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: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: SAb Biotherapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Influenza A H1N1

Interventions

Type	Name	Description
BIOLOGICAL	SAB-176	Treatment of influenza
OTHER	Placebo	Placebo Control

Timeline

• Start date: 2021-06-23
• Primary completion: 2021-10-08
• Completion: 2021-10-08
• First posted: 2021-04-20
• Last updated: 2025-01-22
• Results posted: 2025-01-22

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study