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VAL-506440

Phase 1

Influenza | Monoclonal antibody | Infectious Disease |Moderna, Inc.|Last Updated: Apr 22, 2022

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 Enrollment201
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03076385Safety, Tolerability, and Immunogenicity of VAL-506440 in Healthy Adult SubjectsPHASE1 COMPLETED 201Dec 1, 2015Oct 1, 2018Apr 22, 20221 Germany
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Study Endpoints
Primary Endpoints
Types, frequency, and severity of serious adverse events (SAE), adverse events of special interest (AESI), and adverse events considered related to study drug
Through 13 months of study participation
Secondary Endpoints
Frequency of hemagglutinin inhibition (HAI) seroconversion measured by a neutralization assay in comparison with baseline samples
Through 13 months of study participation
Frequency of microneutralization seroconversion measured by a neutralization assay in comparison with baseline samples
Through 13 months of study participation
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
VAL-506440EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
VAL-506440BIOLOGICALEscalating dose levels
PlaceboOTHER -
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Eligibility Criteria
Age Range18 Years — 64 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion * Agrees to comply with the study procedures and provides written informed consent * 18 to 64 years of age * Body mass index between 18 and 30 kg/m2 * Negative urine pregnancy test at the Screening visit and the day of each vaccination. * Female subjects must either be of non-childbearing...

Countries:Germany
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