Phase 2a Influenza Human Challenge Study of SAB 176 in Healthy Adult Participants

• Research type

  Research Study

• Full 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.

• IRAS ID

  1003707

• Contact name

  Rick Finnigan

• Sponsor organisation

  SAB Biotherapeutics, Inc.

• Eudract number

  2021-001254-56

• Research summary

  Summary of Research
  The purpose of this study is to investigate experimental treatment SAB-176 for influenza infection caused by influenza viruses.
  Up to 60 healthy volunteers 18-45 years of age who consent to the participation in this research will be invited to a Quarantine unit at hVIVO, to stay for approximately 8 days.
  To test the study drug, healthy participants will be infected (inoculated) with a flu virus, which is called Influenza A/California/2009 H1N1, in a Quarantine residential facility. Following the inoculation, on the next day, participants will be given study drug SAB-176 or placebo administered by an intravenous infusion (IV). SAB-176 and placebo will be allocated at random in a 1:1 ratio and in a blinded manner. This means that Participants, research staff and study sponsor will not know which volunteer received SAB-176 or placebo.
  After completion of the Quarantine phase which will last approximately 11 days from admission to a discharge day, participants will need to return for a final follow up visit. The visit will take place approximately Day 28 (+/-3 days) from the day of receiving the SAB-176 / Placebo treatment.

  Summary of Results
  All enrolled participants (N=62), who signed the study-specific ICF and met the eligibility criteria, were randomised, and inoculated with the challenge virus. Two participants (1 in each treatment group) were inoculated with challenge virus but were not treated with IMP. In total, 60 participants were treated (30 with SAB-176 and 30 with placebo). One participant (in the SAB-176 group) voluntarily left the quarantine unit before Day 8 (on Day 7) against investigator advice which was considered a major protocol deviation. This participant was therefore excluded from the PP analysis set prior to unblinding of treatment group assignment and primary and secondary endpoints were known. All 62 were followed .

• REC name

  South Central - Hampshire A Research Ethics Committee

• REC reference

  21/SC/0108

• Date of REC Opinion

  7 Jun 2021

• REC opinion

  Further Information Favourable Opinion