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SAB-176

Phase 2

Influenza A H1N1 | Monoclonal antibody | Infectious Disease |SAB Biotherapeutics, Inc.|Last Updated: Jan 22, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment62
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04850898Study of SAB-176 in Healthy Adult ParticipantsPHASE2 COMPLETED 62Jun 23, 2021Oct 8, 2021Jan 22, 20251 United Kingdom
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Study Endpoints
Primary Endpoints
To Evaluate Viral Load by Quantitative Reverse Transcriptase-Polymerase Chain Reaction (qRT-PCR) of SAB-176 When Compared to Placebo
28 Days

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.

Secondary Endpoints
Evaluate Peak Viral Load Quantified by qRT-PCR.
28 Days
Evaluate Duration of Influenza Quantified by qRT-PCR.
28 Days
Evaluate Peak Viral Load Determined by Cell Culture.
28 Days
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Normal Saline Placebo ControlPLACEBO_COMPARATORPlacebo control dosed 1 time via intravenous infusion
SAB-176 - 25mg/kgEXPERIMENTALInvestigational Medicinal Product dosed 1 time at 25 mg/kg on day 1 via intravenous infusion
Interventions
NameTypeDescription
SAB-176BIOLOGICALTreatment of influenza
PlaceboOTHERPlacebo Control
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Eligibility Criteria
Age Range18 Years — 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. An informed consent document signed and dated by the participant and the investigator 2. Aged between 18 and 45 years on the day of signing the study specific ICF. 3. In good health with no history, or current evidence, of clinically significant medical conditions, and no cli...

Countries:United Kingdom
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