Healthy adult participants will be challenged with the H1N1 Influenza virus and then treated with either SAB-176 or placebo.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
62
Queen Mary BioEnterprises Innovation Centre
London, United Kingdom
To Evaluate Viral Load by Quantitative Reverse Transcriptase-Polymerase Chain Reaction (qRT-PCR) of SAB-176 When Compared to Placebo
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.
Time frame: 28 Days
Evaluate Peak Viral Load Quantified by qRT-PCR.
Peak viral load as defined by the maximum viral load determined by quantifiable qRT-PCR measurements to evaluate the effect of SAB-176 in reducing viral loads in qRT-PCR due to Influenza A/California/2009 H1N1 virus compared to placebo.
Time frame: 28 Days
Evaluate Duration of Influenza Quantified by qRT-PCR.
Duration in hours of Influenza quantifiable qRT-PCR measurements to evaluate the effect of SAB-176 in reducing the duration of Influenza in qRT-PCR due to Influenza A/California/2009 H1N1 virus compared to placebo.
Time frame: 28 Days
Evaluate Peak Viral Load Determined by Cell Culture.
Peak viral load as defined by the maximum viral load determined by quantifiable cell culture to evaluate the effect of SAB-176 in reducing viral loads in cell culture due to Influenza A/California/2009 H1N1 virus, compared to placebo.
Time frame: 28 Days
Evaluate Peak Viral Load Area Under the Curve Determined by Cell Culture.
VL-AUC of Influenza A/California/2009 H1N1 virus as determined by cell culture to evaluate the effect of SB-176 in reducing viral loads in cell culture due to Influenza A/California/2009 H1N1 virus, compared to placebo.
Time frame: 28 Days
Duration of Influenza Using Peak Viral Load Determined by Cell Culture.
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Duration measured in hours of influenza quantifiable by cell culture measurement to evaluate the effect of SB-176 in reducing viral loads in cell culture due to Influenza A/California/2009 H1N1 virus, compared to placebo.
Time frame: 28 Days
TSS-AUC (Area Under the Curve Over Time of Total Clinical Symptoms Score) Measured by Graded Symptom Scoring System to Evaluate the Effect of SAB-176 in Reducing Symptoms Due to Influenza A/California/2009 H1N1 Virus Compared to Placebo.
Using the hVIVO Symptom Diary Card, participants grade 11 distinct cold symptoms on a scale of 0-3 (Grade 0: No symptoms; Grade 1: just noticeable; Grade 2: clearly bothersome from time to time but does not interfere with me doing my normal daily activities; Grade 3: Quite bothersome most or all the time, and it stops me participating in activities) and Shortness of Breath and Wheeze have a scale of 0-4 with 0-3 being the same and grade 4 being symptoms at rest. Additional to symptom card, a Visual Analogue Scale dairy card using a 0mm to 100mm scale, with the same 13 symptoms with 0mm being no symptoms. Total summed grading scale is 0 to 1341. Lower scores represent a better outcome.
Time frame: 28 Days
Peak Symptom Diary Card Score
Peak symptom diary card score: peak total clinical symptoms (TSS) as measured by graded symptom scoring system to evaluate the effect of SAB-176 in reducing symptoms due to Influenza A/California/2009 H1N1 virus compared to placebo. Using the hVIVO Symptom Diary Card, participants grade 11 distinct cold symptoms on a scale of 0-3 (Grade 0: No symptoms; Grade 1: just noticeable; Grade 2: clearly bothersome from time to time but does not interfere with me doing my normal daily activities; Grade 3: Quite bothersome most or all the time, and it stops me participating in activities) and Shortness of Breath and Wheeze have a scale of 0-4 with 0-3 being the same and grade 4 being symptoms at rest. Additional to symptom card, a Visual Analogue Scale dairy card using a 0mm to 100mm scale, with the same 13 symptoms with 0mm being no symptoms. Total summed grading scale is 0 to 1341. Lower scores represent a better outcome.
Time frame: 28 Days
Peak Daily Symptom Score
Peak symptom diary card score: The individual maximum daily sum of symptom score; peak TSS as measured by graded symptom scoring system to evaluate the effect of SAB-176 in reducing symptoms due to Influenza A/California/2009 H1N1 virus compared to placebo. Using the hVIVO Symptom Diary Card, participants grade 11 distinct cold symptoms on a scale of 0-3 (Grade 0: No symptoms; Grade 1: just noticeable; Grade 2: clearly bothersome from time to time but does not interfere with me doing my normal daily activities; Grade 3: Quite bothersome most or all the time, and it stops me participating in activities) and Shortness of Breath and Wheeze have a scale of 0-4 with 0-3 being the same and grade 4 being symptoms at rest. Additional to symptom card, a Visual Analogue Scale dairy card using a 0mm to 100mm scale, with the same 13 symptoms with 0mm being no symptoms. Total summed grading scale is 0 to 1341. Lower scores represent a better outcome.
Time frame: 28 Days
Percent of Participants With Grade 2 or Higher Symptoms.
Number (percent) of participants with Grade 2 or higher symptoms to evaluate the effect of SAB-176 in reducing symptoms due to Influenza A/California/2009 H1N1 virus compared to placebo.
Time frame: 28 Days
RT-PCR Confirmed Symptomatic Influenza Infection.
RT-PCR-confirmed influenza infection (any 2 quantifiable \[≥ lower limit of quantification {LLOQ}\] qRT-PCR measurements reported) over 4 consecutive scheduled timepoints, from morning of Day 2 up to Day 8 (discharge from quarantine) AND clinical symptoms (grade 2 or more symptoms) between Day 2 and quarantine discharge.
Time frame: 28 Days
Culture Lab-confirmed Reduction of Symptomatic Influenza Infection.
Culture lab-confirmed reduction of symptomatic influenza infection defined as: lab-confirmed culturable influenza infection and clinical symptoms to evaluate the effect of SAB-176 in reducing the incidence of symptomatic infection due to Influenza A/California/2009 H1N1 virus compared to placebo.
Time frame: 28 Days
Total Number of Participants That Any Adverse Event (AE) Was Reported for Which Occurred Across All Participants From IV Infusion up to Day 28 Follow-up.
Total number of participants that any adverse events (AEs) that occurred across all participants was reported; Captured from IV infusion up to Day 28 follow-up to evaluate the safety of SAB-176 when compared to placebo.
Time frame: 28 Days
Occurrence of Serious Adverse Events (SAEs) From IV Infusion up to Day 28 Follow up.
Total number, by occurrence, of serious adverse events (SAEs) from IV infusion up to Day 28 follow up to evaluate the safety of SAB-176 when compared to placebo.
Time frame: 28 Days