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AdCOVID

Phase 1

Healthy Volunteers | Monoclonal antibody | Other |Altimmune, Inc.|Last Updated: Aug 14, 2023

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_CONTROLLEDBiomarker
Total Trials1
Total Enrollment92
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04679909Safety and Immunogenicity of AdCOVID in Healthy Adults (COVID-19 Vaccine Study)PHASE1 COMPLETED 92Feb 25, 2021Dec 21, 2022Aug 14, 20236 United States
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Study Endpoints
Primary Endpoints
Reactogenicity
For 7 days after vaccination

Counts and percentages of subjects with local and systemic events

Adverse Events (AEs)
Day 1 to Day 57

Counts and percentages of subjects with AEs

Secondary Endpoints
Anti-SARS-CoV-2 spike IgG antibody levels
Day 1 to Day 366
Neutralizing antibody titer against live and/or pseudotyped SARS-CoV-2 virus
Day 1 to Day 366
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Single Low Dose AdCOVIDEXPERIMENTAL -
Single Medium Dose AdCOVIDEXPERIMENTAL -
Single High Dose AdCOVIDEXPERIMENTAL -
Two Low Doses AdCOVIDEXPERIMENTAL -
Two Medium Doses AdCOVIDEXPERIMENTAL -
Two High Doses AdCOVIDEXPERIMENTAL -
Single Dose PlaceboPLACEBO_COMPARATOR -
Two Dose PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
AdCOVIDBIOLOGICALAdministered intranasally
PlaceboOTHERAdministered intranasally
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites6

Inclusion Criteria: * Men and women ages 18 to 55 years, inclusive * Good general health status * Screening laboratory results within institutional normal range or Grade 1 abnormality if the Investigator documents clinical insignificance. Grade 2 laboratories may be permissible if considered not cl...

Countries:United States
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