Trial Outcomes & Findings for Study of SAB-176 in Healthy Adult Participants (NCT NCT04850898)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

62 participants

Primary outcome timeframe

28 Days

Results posted on

2025-01-22

Participant Flow

A total of 62 healthy adult participants were randomised and inoculated with the challenge virus of which 30 participants were treated with SAB-176 and 30 participants with placebo. Two participants that were inoculated with challenge virus were not treated with investigational medicinal product (1 in each treatment group) and were not included in the intent-to-treat (ITT) and safety analysis sets (and in the per protocol \[PP\], ITT-infected \[ITT-I\] or ITT-I sensitivity \[ITT-Is\] analysis sets).

Two participants (1 in each treatment group) were inoculated with challenge virus but were not treated with Investigational Medicinal Product (IMP). In total, 60 participants were treated (30 with SAB-176 and 30 with placebo).

Participant milestones

Participant milestones
Measure	Normal Saline Placebo Control Placebo control dosed 1 time via intravenous infusion Placebo: Placebo Control	SAB-176 - 25mg/kg Investigational Medicinal Product dosed 1 time at 25 mg/kg on day 1 via intravenous infusion SAB-176: Treatment of influenza
Overall Study STARTED	31	31
Overall Study COMPLETED	30	30
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Normal Saline Placebo Control Placebo control dosed 1 time via intravenous infusion Placebo: Placebo Control	SAB-176 - 25mg/kg Investigational Medicinal Product dosed 1 time at 25 mg/kg on day 1 via intravenous infusion SAB-176: Treatment of influenza
Overall Study Inoculated with challenge virus but were not treated with IMP	1	1

Baseline Characteristics

Two participants that were inoculated with challenge virus were not treated with investigational medicinal product (IMP) (1 in each treatment group) and were not included in the intent-to-treat (ITT) and safety analysis sets (and in the per protocol \[PP\], ITT-infected \[ITT-I\] or ITT-I sensitivity \[ITT-Is\] analysis sets).

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 28 Days

Population: All participants randomly assigned to study intervention who received the study intervention (ITT analysis set participants) who had no major protocol deviation likely to impact the efficacy evaluation, and who completed the quarantine period up to the final day of quarantine (Day 8) Participant 542996 was excluded from the PP analysis set due to a major protocol deviation prior to unblinding of treatment group assignment and primary and secondary endpoints were known.

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.

Outcome measures

Outcome measures
Measure	Normal Saline Placebo Control n=30 Participants Placebo control dosed 1 time via intravenous infusion Placebo: Placebo Control	SAB-176 - 25mg/kg n=29 Participants Investigational Medicinal Product dosed 1 time at 25 mg/kg on day 1 via intravenous infusion SAB-176: Treatment of influenza
To Evaluate Viral Load by Quantitative Reverse Transcriptase-Polymerase Chain Reaction (qRT-PCR) of SAB-176 When Compared to Placebo	273.05 Log10 copies*hour/mL Standard Deviation 337.247	91.98 Log10 copies*hour/mL Standard Deviation 166.034

SECONDARY outcome

Timeframe: 28 Days

Population: All participants randomly assigned to study intervention who received the study intervention (ITT analysis set participants) who had no major protocol deviation likely to impact the efficacy evaluation, and who completed the quarantine period up to the final day of quarantine (Day 8) Participant 542996 was excluded from the PP analysis set due to a major protocol deviation prior to unblinding of treatment group assignment and primary and secondary endpoints were known.

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.

Outcome measures

Outcome measures
Measure	Normal Saline Placebo Control n=30 Participants Placebo control dosed 1 time via intravenous infusion Placebo: Placebo Control	SAB-176 - 25mg/kg n=29 Participants Investigational Medicinal Product dosed 1 time at 25 mg/kg on day 1 via intravenous infusion SAB-176: Treatment of influenza
Evaluate Peak Viral Load Quantified by qRT-PCR.	3.8196 Log10 copies/mL Standard Deviation 3.73236	2.5440 Log10 copies/mL Standard Deviation 3.37243

SECONDARY outcome

Timeframe: 28 Days

Population: All participants randomly assigned to study intervention who received the study intervention (ITT analysis set participants) who had no major protocol deviation likely to impact the efficacy evaluation, and who completed the quarantine period up to the final day of quarantine (Day 8) Participant 542996 was excluded from the PP analysis set due to a major protocol deviation prior to unblinding of treatment group assignment and primary and secondary endpoints were known.

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.

Outcome measures

Outcome measures
Measure	Normal Saline Placebo Control n=30 Participants Placebo control dosed 1 time via intravenous infusion Placebo: Placebo Control	SAB-176 - 25mg/kg n=29 Participants Investigational Medicinal Product dosed 1 time at 25 mg/kg on day 1 via intravenous infusion SAB-176: Treatment of influenza
Evaluate Duration of Influenza Quantified by qRT-PCR.	1.3097 hours Standard Deviation 1.90894	0.5503 hours Standard Deviation 1.24432

SECONDARY outcome

Timeframe: 28 Days

Population: Participant 542996 was excluded from the PP analysis set due to a major protocol deviation prior to unblinding of treatment group assignment and primary and secondary endpoints were known.

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.

Outcome measures

Outcome measures
Measure	Normal Saline Placebo Control n=30 Participants Placebo control dosed 1 time via intravenous infusion Placebo: Placebo Control	SAB-176 - 25mg/kg n=29 Participants Investigational Medicinal Product dosed 1 time at 25 mg/kg on day 1 via intravenous infusion SAB-176: Treatment of influenza
Evaluate Peak Viral Load Determined by Cell Culture.	1.3097 Log10 TCID 50/ml Standard Deviation 1.90894	0.5503 Log10 TCID 50/ml Standard Deviation 1.24432

SECONDARY outcome

Timeframe: 28 Days

Population: Participant 542996 was excluded from the PP analysis set due to a major protocol deviation prior to unblinding of treatment group assignment and primary and secondary endpoints were known.

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.

Outcome measures

Outcome measures
Measure	Normal Saline Placebo Control n=30 Participants Placebo control dosed 1 time via intravenous infusion Placebo: Placebo Control	SAB-176 - 25mg/kg n=29 Participants Investigational Medicinal Product dosed 1 time at 25 mg/kg on day 1 via intravenous infusion SAB-176: Treatment of influenza
Evaluate Peak Viral Load Area Under the Curve Determined by Cell Culture.	67.97 hours * Log10 TCID 50/mL Interval 33.55 to 102.4	7.99 hours * Log10 TCID 50/mL Interval 1.56 to 14.42

SECONDARY outcome

Timeframe: 28 Days

Population: Participant 542996 was excluded from the PP analysis set due to a major protocol deviation prior to unblinding of treatment group assignment and primary and secondary endpoints were known.

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.

Outcome measures

Outcome measures
Measure	Normal Saline Placebo Control n=30 Participants Placebo control dosed 1 time via intravenous infusion Placebo: Placebo Control	SAB-176 - 25mg/kg n=29 Participants Investigational Medicinal Product dosed 1 time at 25 mg/kg on day 1 via intravenous infusion SAB-176: Treatment of influenza
Duration of Influenza Using Peak Viral Load Determined by Cell Culture.	1.3097 hours Standard Deviation 1.90894	0.5503 hours Standard Deviation 1.24432

SECONDARY outcome

Timeframe: 28 Days

Population: All participants randomly assigned to study intervention who received the study intervention (ITT analysis set participants) who had no major protocol deviation likely to impact the efficacy evaluation, and who completed the quarantine period up to the final day of quarantine (Day 8) Participant 542996 was excluded from the PP analysis set due to a major protocol deviation prior to unblinding of treatment group assignment and primary and secondary endpoints were known.

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.

Outcome measures

Outcome measures
Measure	Normal Saline Placebo Control n=30 Participants Placebo control dosed 1 time via intravenous infusion Placebo: Placebo Control	SAB-176 - 25mg/kg n=29 Participants Investigational Medicinal Product dosed 1 time at 25 mg/kg on day 1 via intravenous infusion SAB-176: Treatment of influenza
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.	166.52 Total Symptom Score Scale-points*hour Standard Deviation 282.313	51.06 Total Symptom Score Scale-points*hour Standard Deviation 74.559

SECONDARY outcome

Timeframe: 28 Days

Population: All participants randomly assigned to study intervention who received the study intervention (ITT analysis set participants) who had no major protocol deviation likely to impact the efficacy evaluation, and who completed the quarantine period up to the final day of quarantine (Day 8) Participant 542996 was excluded from the PP analysis set due to a major protocol deviation prior to unblinding of treatment group assignment and primary and secondary endpoints were known.

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.

Outcome measures

Outcome measures
Measure	Normal Saline Placebo Control n=30 Participants Placebo control dosed 1 time via intravenous infusion Placebo: Placebo Control	SAB-176 - 25mg/kg n=29 Participants Investigational Medicinal Product dosed 1 time at 25 mg/kg on day 1 via intravenous infusion SAB-176: Treatment of influenza
Peak Symptom Diary Card Score	3.7 score on a scale Standard Deviation 4.79	1.8 score on a scale Standard Deviation 2.21

SECONDARY outcome

Timeframe: 28 Days

Population: All participants randomly assigned to study intervention who received the study intervention (ITT analysis set participants) who had no major protocol deviation likely to impact the efficacy evaluation, and who completed the quarantine period up to the final day of quarantine (Day 8) Participant 542996 was excluded from the PP analysis set due to a major protocol deviation prior to unblinding of treatment group assignment and primary and secondary endpoints were known.

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.

Outcome measures

Outcome measures
Measure	Normal Saline Placebo Control n=30 Participants Placebo control dosed 1 time via intravenous infusion Placebo: Placebo Control	SAB-176 - 25mg/kg n=29 Participants Investigational Medicinal Product dosed 1 time at 25 mg/kg on day 1 via intravenous infusion SAB-176: Treatment of influenza
Peak Daily Symptom Score	8.3 score on a scale Standard Deviation 11.24	3.6 score on a scale Standard Deviation 5.31

SECONDARY outcome

Timeframe: 28 Days

Population: All participants randomly assigned to study intervention who received the study intervention (ITT analysis set participants) who had no major protocol deviation likely to impact the efficacy evaluation, and who completed the quarantine period up to the final day of quarantine (Day 8) Participant 542996 was excluded from the PP analysis set due to a major protocol deviation prior to unblinding of treatment group assignment and primary and secondary endpoints were known.

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.

Outcome measures

Outcome measures
Measure	Normal Saline Placebo Control n=30 Participants Placebo control dosed 1 time via intravenous infusion Placebo: Placebo Control	SAB-176 - 25mg/kg n=29 Participants Investigational Medicinal Product dosed 1 time at 25 mg/kg on day 1 via intravenous infusion SAB-176: Treatment of influenza
Percent of Participants With Grade 2 or Higher Symptoms.	30 percentage of participants Interval 18.37 to 44.94	20.7 percentage of participants Interval 11.1 to 35.29

SECONDARY outcome

Timeframe: 28 Days

Population: All participants randomly assigned to study intervention who received the study intervention (ITT analysis set participants) who had no major protocol deviation likely to impact the efficacy evaluation, and who completed the quarantine period up to the final day of quarantine (Day 8) Participant 542996 was excluded from the PP analysis set due to a major protocol deviation prior to unblinding of treatment group assignment and primary and secondary endpoints were known.

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.

Outcome measures

Outcome measures
Measure	Normal Saline Placebo Control n=30 Participants Placebo control dosed 1 time via intravenous infusion Placebo: Placebo Control	SAB-176 - 25mg/kg n=29 Participants Investigational Medicinal Product dosed 1 time at 25 mg/kg on day 1 via intravenous infusion SAB-176: Treatment of influenza
RT-PCR Confirmed Symptomatic Influenza Infection.	15 Participants	9 Participants

SECONDARY outcome

Timeframe: 28 Days

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Normal Saline Placebo Control n=30 Participants Placebo control dosed 1 time via intravenous infusion Placebo: Placebo Control	SAB-176 - 25mg/kg n=29 Participants Investigational Medicinal Product dosed 1 time at 25 mg/kg on day 1 via intravenous infusion SAB-176: Treatment of influenza
Culture Lab-confirmed Reduction of Symptomatic Influenza Infection.	6 Participants	2 Participants

SECONDARY outcome

Timeframe: 28 Days

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.

Outcome measures

Outcome measures
Measure	Normal Saline Placebo Control n=30 Participants Placebo control dosed 1 time via intravenous infusion Placebo: Placebo Control	SAB-176 - 25mg/kg n=30 Participants Investigational Medicinal Product dosed 1 time at 25 mg/kg on day 1 via intravenous infusion SAB-176: Treatment of influenza
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.	16 Participants	18 Participants

SECONDARY outcome

Timeframe: 28 Days

Population: All participants who signed an Informed Consent. Two participants (1 in each treatment group) were inoculated with challenge virus but were not treated with IMP.

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.

Outcome measures

Outcome measures
Measure	Normal Saline Placebo Control n=31 Participants Placebo control dosed 1 time via intravenous infusion Placebo: Placebo Control	SAB-176 - 25mg/kg n=31 Participants Investigational Medicinal Product dosed 1 time at 25 mg/kg on day 1 via intravenous infusion SAB-176: Treatment of influenza
Occurrence of Serious Adverse Events (SAEs) From IV Infusion up to Day 28 Follow up.	0 SAE occurrence	0 SAE occurrence

OTHER_PRE_SPECIFIED outcome

Timeframe: 28 Days

Population: All participants randomly assigned to study intervention who received the study intervention (ITT analysis set participants) who had no major protocol deviation likely to impact the efficacy evaluation, and who completed the quarantine period up to the final day of quarantine (Day 8) Participant 542996 was excluded from the PP analysis set due to a major protocol deviation prior to unblinding of treatment group assignment and primary and secondary endpoints were known.

Evaluate number of participants with upper respiratory tract illness to determine the effect of SAB-176 in reducing the incidence of influenza illness due to Influenza A/California/2009 H1N1 virus compared to placebo.

Outcome measures

Outcome measures
Measure	Normal Saline Placebo Control n=30 Participants Placebo control dosed 1 time via intravenous infusion Placebo: Placebo Control	SAB-176 - 25mg/kg n=29 Participants Investigational Medicinal Product dosed 1 time at 25 mg/kg on day 1 via intravenous infusion SAB-176: Treatment of influenza
Number of Participants With Upper Respiratory Tract Illness.	6 Participants	5 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 28 Days

Population: All participants randomly assigned to study intervention who received the study intervention (ITT analysis set participants) who had no major protocol deviation likely to impact the efficacy evaluation, and who completed the quarantine period up to the final day of quarantine (Day 8) Participant 542996 was excluded from the PP analysis set due to a major protocol deviation prior to unblinding of treatment group assignment and primary and secondary endpoints were known.

Evaluate number of participants with lower respiratory tract illness to determine the effect of SAB-176 in reducing the incidence of influenza illness due to Influenza A/California/2009 H1N1 virus compared to placebo.

Outcome measures

Outcome measures
Measure	Normal Saline Placebo Control n=30 Participants Placebo control dosed 1 time via intravenous infusion Placebo: Placebo Control	SAB-176 - 25mg/kg n=29 Participants Investigational Medicinal Product dosed 1 time at 25 mg/kg on day 1 via intravenous infusion SAB-176: Treatment of influenza
Number of Participants With Lower Respiratory Tract Illness.	3 participants	0 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 28 Days

Population: All participants randomly assigned to study intervention who received the study intervention (ITT analysis set participants) who had no major protocol deviation likely to impact the efficacy evaluation, and who completed the quarantine period up to the final day of quarantine (Day 8) Participant 542996 was excluded from the PP analysis set due to a major protocol deviation prior to unblinding of treatment group assignment and primary and secondary endpoints were known.

Evaluate number of participants with systemic illness to determine the effect of SAB-176 in reducing the incidence of influenza illness due to Influenza A/California/2009 H1N1 virus compared to placebo.

Outcome measures

Outcome measures
Measure	Normal Saline Placebo Control n=30 Participants Placebo control dosed 1 time via intravenous infusion Placebo: Placebo Control	SAB-176 - 25mg/kg n=29 Participants Investigational Medicinal Product dosed 1 time at 25 mg/kg on day 1 via intravenous infusion SAB-176: Treatment of influenza
Number of Participants With Systemic Illness.	4 Participants	2 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 28 Days

Evaluate number of participants with mild to moderate symptoms to determine the effect of SAB-176 in reducing the incidence of influenza illness due to Influenza A/California/2009 H1N1 virus compared to placebo.

Outcome measures

Outcome measures
Measure	Normal Saline Placebo Control n=30 Participants Placebo control dosed 1 time via intravenous infusion Placebo: Placebo Control	SAB-176 - 25mg/kg n=29 Participants Investigational Medicinal Product dosed 1 time at 25 mg/kg on day 1 via intravenous infusion SAB-176: Treatment of influenza
Number of Participants With Mild to Moderate Symptoms.	30 percentage of participants Interval 18.37 to 44.94	20.7 percentage of participants Interval 11.1 to 35.29

OTHER_PRE_SPECIFIED outcome

Timeframe: 28 Days

Population: Participant 542996 was excluded from the PP analysis set due to a major protocol deviation prior to unblinding of treatment group assignment and primary and secondary endpoints were known. 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 Day 8 (discharge from quarantine) AND clinical symptoms (grade 2 or more symptoms) between Day 2 and discharge.

Influenza viral infection rates in upper respiratory samples by qRT-PCR to explore the effect of SAB-176 in reducing the incidence of infection due to Influenza A/California H1N1 Virus.

Outcome measures

Outcome measures
Measure	Normal Saline Placebo Control n=30 Participants Placebo control dosed 1 time via intravenous infusion Placebo: Placebo Control	SAB-176 - 25mg/kg n=29 Participants Investigational Medicinal Product dosed 1 time at 25 mg/kg on day 1 via intravenous infusion SAB-176: Treatment of influenza
Influenza Viral Infection Rates in Upper Respiratory Samples by qRT-PCR	8 Participants	2 Participants

Adverse Events

Normal Saline Placebo Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

SAB-176

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Senior Director Clinical Operations

SAB Biotherapeutics

Phone: 8326221699

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Normal Saline Placebo Control n=30 Participants Placebo control dosed 1 time via intravenous infusion Placebo: Placebo Control	SAB-176 - 25mg/kg n=30 Participants Investigational Medicinal Product dosed 1 time at 25 mg/kg on day 1 via intravenous infusion SAB-176: Treatment of influenza	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	1 Participants n=5 Participants • Two participants that were inoculated with challenge virus were not treated with investigational medicinal product (IMP) (1 in each treatment group) and were not included in the intent-to-treat (ITT) and safety analysis sets (and in the per protocol \[PP\], ITT-infected \[ITT-I\] or ITT-I sensitivity \[ITT-Is\] analysis sets).	0 Participants n=7 Participants • Two participants that were inoculated with challenge virus were not treated with investigational medicinal product (IMP) (1 in each treatment group) and were not included in the intent-to-treat (ITT) and safety analysis sets (and in the per protocol \[PP\], ITT-infected \[ITT-I\] or ITT-I sensitivity \[ITT-Is\] analysis sets).	1 Participants n=5 Participants • Two participants that were inoculated with challenge virus were not treated with investigational medicinal product (IMP) (1 in each treatment group) and were not included in the intent-to-treat (ITT) and safety analysis sets (and in the per protocol \[PP\], ITT-infected \[ITT-I\] or ITT-I sensitivity \[ITT-Is\] analysis sets).
Age, Categorical Between 18 and 65 years	29 Participants n=5 Participants • Two participants that were inoculated with challenge virus were not treated with investigational medicinal product (IMP) (1 in each treatment group) and were not included in the intent-to-treat (ITT) and safety analysis sets (and in the per protocol \[PP\], ITT-infected \[ITT-I\] or ITT-I sensitivity \[ITT-Is\] analysis sets).	30 Participants n=7 Participants • Two participants that were inoculated with challenge virus were not treated with investigational medicinal product (IMP) (1 in each treatment group) and were not included in the intent-to-treat (ITT) and safety analysis sets (and in the per protocol \[PP\], ITT-infected \[ITT-I\] or ITT-I sensitivity \[ITT-Is\] analysis sets).	59 Participants n=5 Participants • Two participants that were inoculated with challenge virus were not treated with investigational medicinal product (IMP) (1 in each treatment group) and were not included in the intent-to-treat (ITT) and safety analysis sets (and in the per protocol \[PP\], ITT-infected \[ITT-I\] or ITT-I sensitivity \[ITT-Is\] analysis sets).
Age, Categorical >=65 years	0 Participants n=5 Participants • Two participants that were inoculated with challenge virus were not treated with investigational medicinal product (IMP) (1 in each treatment group) and were not included in the intent-to-treat (ITT) and safety analysis sets (and in the per protocol \[PP\], ITT-infected \[ITT-I\] or ITT-I sensitivity \[ITT-Is\] analysis sets).	0 Participants n=7 Participants • Two participants that were inoculated with challenge virus were not treated with investigational medicinal product (IMP) (1 in each treatment group) and were not included in the intent-to-treat (ITT) and safety analysis sets (and in the per protocol \[PP\], ITT-infected \[ITT-I\] or ITT-I sensitivity \[ITT-Is\] analysis sets).	0 Participants n=5 Participants • Two participants that were inoculated with challenge virus were not treated with investigational medicinal product (IMP) (1 in each treatment group) and were not included in the intent-to-treat (ITT) and safety analysis sets (and in the per protocol \[PP\], ITT-infected \[ITT-I\] or ITT-I sensitivity \[ITT-Is\] analysis sets).
Age, Continuous	24.5 years n=5 Participants • Two participants that were inoculated with challenge virus were not treated with investigational medicinal product (IMP) (1 in each treatment group) and were not included in the intent-to-treat (ITT) and safety analysis sets (and in the per protocol \[PP\], ITT-infected \[ITT-I\] or ITT-I sensitivity \[ITT-Is\] analysis sets).	23 years n=7 Participants • Two participants that were inoculated with challenge virus were not treated with investigational medicinal product (IMP) (1 in each treatment group) and were not included in the intent-to-treat (ITT) and safety analysis sets (and in the per protocol \[PP\], ITT-infected \[ITT-I\] or ITT-I sensitivity \[ITT-Is\] analysis sets).	23.5 years n=5 Participants • Two participants that were inoculated with challenge virus were not treated with investigational medicinal product (IMP) (1 in each treatment group) and were not included in the intent-to-treat (ITT) and safety analysis sets (and in the per protocol \[PP\], ITT-infected \[ITT-I\] or ITT-I sensitivity \[ITT-Is\] analysis sets).
Sex: Female, Male Female	8 Participants n=5 Participants • Two participants that were inoculated with challenge virus were not treated with investigational medicinal product (IMP) (1 in each treatment group) and were not included in the intent-to-treat (ITT) and safety analysis sets (and in the per protocol \[PP\], ITT-infected \[ITT-I\] or ITT-I sensitivity \[ITT-Is\] analysis sets).	10 Participants n=7 Participants • Two participants that were inoculated with challenge virus were not treated with investigational medicinal product (IMP) (1 in each treatment group) and were not included in the intent-to-treat (ITT) and safety analysis sets (and in the per protocol \[PP\], ITT-infected \[ITT-I\] or ITT-I sensitivity \[ITT-Is\] analysis sets).	18 Participants n=5 Participants • Two participants that were inoculated with challenge virus were not treated with investigational medicinal product (IMP) (1 in each treatment group) and were not included in the intent-to-treat (ITT) and safety analysis sets (and in the per protocol \[PP\], ITT-infected \[ITT-I\] or ITT-I sensitivity \[ITT-Is\] analysis sets).
Sex: Female, Male Male	22 Participants n=5 Participants • Two participants that were inoculated with challenge virus were not treated with investigational medicinal product (IMP) (1 in each treatment group) and were not included in the intent-to-treat (ITT) and safety analysis sets (and in the per protocol \[PP\], ITT-infected \[ITT-I\] or ITT-I sensitivity \[ITT-Is\] analysis sets).	20 Participants n=7 Participants • Two participants that were inoculated with challenge virus were not treated with investigational medicinal product (IMP) (1 in each treatment group) and were not included in the intent-to-treat (ITT) and safety analysis sets (and in the per protocol \[PP\], ITT-infected \[ITT-I\] or ITT-I sensitivity \[ITT-Is\] analysis sets).	42 Participants n=5 Participants • Two participants that were inoculated with challenge virus were not treated with investigational medicinal product (IMP) (1 in each treatment group) and were not included in the intent-to-treat (ITT) and safety analysis sets (and in the per protocol \[PP\], ITT-infected \[ITT-I\] or ITT-I sensitivity \[ITT-Is\] analysis sets).
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants • Two participants that were inoculated with challenge virus were not treated with investigational medicinal product (IMP) (1 in each treatment group) and were not included in the intent-to-treat (ITT) and safety analysis sets (and in the per protocol \[PP\], ITT-infected \[ITT-I\] or ITT-I sensitivity \[ITT-Is\] analysis sets).	1 Participants n=7 Participants • Two participants that were inoculated with challenge virus were not treated with investigational medicinal product (IMP) (1 in each treatment group) and were not included in the intent-to-treat (ITT) and safety analysis sets (and in the per protocol \[PP\], ITT-infected \[ITT-I\] or ITT-I sensitivity \[ITT-Is\] analysis sets).	1 Participants n=5 Participants • Two participants that were inoculated with challenge virus were not treated with investigational medicinal product (IMP) (1 in each treatment group) and were not included in the intent-to-treat (ITT) and safety analysis sets (and in the per protocol \[PP\], ITT-infected \[ITT-I\] or ITT-I sensitivity \[ITT-Is\] analysis sets).
Ethnicity (NIH/OMB) Not Hispanic or Latino	30 Participants n=5 Participants • Two participants that were inoculated with challenge virus were not treated with investigational medicinal product (IMP) (1 in each treatment group) and were not included in the intent-to-treat (ITT) and safety analysis sets (and in the per protocol \[PP\], ITT-infected \[ITT-I\] or ITT-I sensitivity \[ITT-Is\] analysis sets).	29 Participants n=7 Participants • Two participants that were inoculated with challenge virus were not treated with investigational medicinal product (IMP) (1 in each treatment group) and were not included in the intent-to-treat (ITT) and safety analysis sets (and in the per protocol \[PP\], ITT-infected \[ITT-I\] or ITT-I sensitivity \[ITT-Is\] analysis sets).	59 Participants n=5 Participants • Two participants that were inoculated with challenge virus were not treated with investigational medicinal product (IMP) (1 in each treatment group) and were not included in the intent-to-treat (ITT) and safety analysis sets (and in the per protocol \[PP\], ITT-infected \[ITT-I\] or ITT-I sensitivity \[ITT-Is\] analysis sets).
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants • Two participants that were inoculated with challenge virus were not treated with investigational medicinal product (IMP) (1 in each treatment group) and were not included in the intent-to-treat (ITT) and safety analysis sets (and in the per protocol \[PP\], ITT-infected \[ITT-I\] or ITT-I sensitivity \[ITT-Is\] analysis sets).	0 Participants n=7 Participants • Two participants that were inoculated with challenge virus were not treated with investigational medicinal product (IMP) (1 in each treatment group) and were not included in the intent-to-treat (ITT) and safety analysis sets (and in the per protocol \[PP\], ITT-infected \[ITT-I\] or ITT-I sensitivity \[ITT-Is\] analysis sets).	0 Participants n=5 Participants • Two participants that were inoculated with challenge virus were not treated with investigational medicinal product (IMP) (1 in each treatment group) and were not included in the intent-to-treat (ITT) and safety analysis sets (and in the per protocol \[PP\], ITT-infected \[ITT-I\] or ITT-I sensitivity \[ITT-Is\] analysis sets).
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants • Two participants that were inoculated with challenge virus were not treated with investigational medicinal product (IMP) (1 in each treatment group) and were not included in the intent-to-treat (ITT) and safety analysis sets (and in the per protocol \[PP\], ITT-infected \[ITT-I\] or ITT-I sensitivity \[ITT-Is\] analysis sets).	0 Participants n=7 Participants • Two participants that were inoculated with challenge virus were not treated with investigational medicinal product (IMP) (1 in each treatment group) and were not included in the intent-to-treat (ITT) and safety analysis sets (and in the per protocol \[PP\], ITT-infected \[ITT-I\] or ITT-I sensitivity \[ITT-Is\] analysis sets).	0 Participants n=5 Participants • Two participants that were inoculated with challenge virus were not treated with investigational medicinal product (IMP) (1 in each treatment group) and were not included in the intent-to-treat (ITT) and safety analysis sets (and in the per protocol \[PP\], ITT-infected \[ITT-I\] or ITT-I sensitivity \[ITT-Is\] analysis sets).
Race (NIH/OMB) Asian	1 Participants n=5 Participants • Two participants that were inoculated with challenge virus were not treated with investigational medicinal product (IMP) (1 in each treatment group) and were not included in the intent-to-treat (ITT) and safety analysis sets (and in the per protocol \[PP\], ITT-infected \[ITT-I\] or ITT-I sensitivity \[ITT-Is\] analysis sets).	1 Participants n=7 Participants • Two participants that were inoculated with challenge virus were not treated with investigational medicinal product (IMP) (1 in each treatment group) and were not included in the intent-to-treat (ITT) and safety analysis sets (and in the per protocol \[PP\], ITT-infected \[ITT-I\] or ITT-I sensitivity \[ITT-Is\] analysis sets).	2 Participants n=5 Participants • Two participants that were inoculated with challenge virus were not treated with investigational medicinal product (IMP) (1 in each treatment group) and were not included in the intent-to-treat (ITT) and safety analysis sets (and in the per protocol \[PP\], ITT-infected \[ITT-I\] or ITT-I sensitivity \[ITT-Is\] analysis sets).
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants • Two participants that were inoculated with challenge virus were not treated with investigational medicinal product (IMP) (1 in each treatment group) and were not included in the intent-to-treat (ITT) and safety analysis sets (and in the per protocol \[PP\], ITT-infected \[ITT-I\] or ITT-I sensitivity \[ITT-Is\] analysis sets).	0 Participants n=7 Participants • Two participants that were inoculated with challenge virus were not treated with investigational medicinal product (IMP) (1 in each treatment group) and were not included in the intent-to-treat (ITT) and safety analysis sets (and in the per protocol \[PP\], ITT-infected \[ITT-I\] or ITT-I sensitivity \[ITT-Is\] analysis sets).	0 Participants n=5 Participants • Two participants that were inoculated with challenge virus were not treated with investigational medicinal product (IMP) (1 in each treatment group) and were not included in the intent-to-treat (ITT) and safety analysis sets (and in the per protocol \[PP\], ITT-infected \[ITT-I\] or ITT-I sensitivity \[ITT-Is\] analysis sets).
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants • Two participants that were inoculated with challenge virus were not treated with investigational medicinal product (IMP) (1 in each treatment group) and were not included in the intent-to-treat (ITT) and safety analysis sets (and in the per protocol \[PP\], ITT-infected \[ITT-I\] or ITT-I sensitivity \[ITT-Is\] analysis sets).	3 Participants n=7 Participants • Two participants that were inoculated with challenge virus were not treated with investigational medicinal product (IMP) (1 in each treatment group) and were not included in the intent-to-treat (ITT) and safety analysis sets (and in the per protocol \[PP\], ITT-infected \[ITT-I\] or ITT-I sensitivity \[ITT-Is\] analysis sets).	6 Participants n=5 Participants • Two participants that were inoculated with challenge virus were not treated with investigational medicinal product (IMP) (1 in each treatment group) and were not included in the intent-to-treat (ITT) and safety analysis sets (and in the per protocol \[PP\], ITT-infected \[ITT-I\] or ITT-I sensitivity \[ITT-Is\] analysis sets).
Race (NIH/OMB) White	22 Participants n=5 Participants • Two participants that were inoculated with challenge virus were not treated with investigational medicinal product (IMP) (1 in each treatment group) and were not included in the intent-to-treat (ITT) and safety analysis sets (and in the per protocol \[PP\], ITT-infected \[ITT-I\] or ITT-I sensitivity \[ITT-Is\] analysis sets).	20 Participants n=7 Participants • Two participants that were inoculated with challenge virus were not treated with investigational medicinal product (IMP) (1 in each treatment group) and were not included in the intent-to-treat (ITT) and safety analysis sets (and in the per protocol \[PP\], ITT-infected \[ITT-I\] or ITT-I sensitivity \[ITT-Is\] analysis sets).	42 Participants n=5 Participants • Two participants that were inoculated with challenge virus were not treated with investigational medicinal product (IMP) (1 in each treatment group) and were not included in the intent-to-treat (ITT) and safety analysis sets (and in the per protocol \[PP\], ITT-infected \[ITT-I\] or ITT-I sensitivity \[ITT-Is\] analysis sets).
Race (NIH/OMB) More than one race	0 Participants n=5 Participants • Two participants that were inoculated with challenge virus were not treated with investigational medicinal product (IMP) (1 in each treatment group) and were not included in the intent-to-treat (ITT) and safety analysis sets (and in the per protocol \[PP\], ITT-infected \[ITT-I\] or ITT-I sensitivity \[ITT-Is\] analysis sets).	0 Participants n=7 Participants • Two participants that were inoculated with challenge virus were not treated with investigational medicinal product (IMP) (1 in each treatment group) and were not included in the intent-to-treat (ITT) and safety analysis sets (and in the per protocol \[PP\], ITT-infected \[ITT-I\] or ITT-I sensitivity \[ITT-Is\] analysis sets).	0 Participants n=5 Participants • Two participants that were inoculated with challenge virus were not treated with investigational medicinal product (IMP) (1 in each treatment group) and were not included in the intent-to-treat (ITT) and safety analysis sets (and in the per protocol \[PP\], ITT-infected \[ITT-I\] or ITT-I sensitivity \[ITT-Is\] analysis sets).
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants • Two participants that were inoculated with challenge virus were not treated with investigational medicinal product (IMP) (1 in each treatment group) and were not included in the intent-to-treat (ITT) and safety analysis sets (and in the per protocol \[PP\], ITT-infected \[ITT-I\] or ITT-I sensitivity \[ITT-Is\] analysis sets).	6 Participants n=7 Participants • Two participants that were inoculated with challenge virus were not treated with investigational medicinal product (IMP) (1 in each treatment group) and were not included in the intent-to-treat (ITT) and safety analysis sets (and in the per protocol \[PP\], ITT-infected \[ITT-I\] or ITT-I sensitivity \[ITT-Is\] analysis sets).	10 Participants n=5 Participants • Two participants that were inoculated with challenge virus were not treated with investigational medicinal product (IMP) (1 in each treatment group) and were not included in the intent-to-treat (ITT) and safety analysis sets (and in the per protocol \[PP\], ITT-infected \[ITT-I\] or ITT-I sensitivity \[ITT-Is\] analysis sets).
Region of Enrollment United Kingdom	30 participants n=5 Participants	30 participants n=7 Participants	60 participants n=5 Participants