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mRNA-1769

Phase 1

Smallpox | Monoclonal antibody | Other |Moderna, Inc.|Last Updated: Jul 16, 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_CONTROLLEDBiomarker
Total Trials1
Total Enrollment351
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05995275A Study to Investigate The Safety, Tolerability, And Immune Response of a Range of Doses of mRNA-1769 Compared With Placebo in Healthy Participants From ≥18 Years of Age to <50 Years of AgePHASE1 COMPLETED 351 — — Aug 15, 2023Jul 8, 2025Jul 16, 202512 United Kingdom
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Study Endpoints
Primary Endpoints
Number of Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs) Through 7 Days After Each Investigational Medicinal Product (IMP)
Up to Day 35
Number of Unsolicited Adverse Events (AEs) Through 7 Days After Each IMP
Up to Day 57
Number of Participants with Medically-Attended AEs (MAAEs)
Day 1 up to Day 395
Number of Participants with Adverse Events of Special Interest (AESIs)
Day 1 up to Day 395
Number of Participants with Serious Adverse Events (SAEs)
Day 1 up to Day 395
Number of Participants with AEs Leading to Study and/or Treatment Discontinuation
Day 1 up to Day 395
Secondary Endpoints
Geometric Mean Titer (GMT) of Neutralising Antibody (nAb) against Mpox Virus (MPXV) by Plaque reduction neutralisation test (PRNT)
Days 1 and 43
Percentage of Participants With Seroconversion Based on Neutralising Antibody Responses Against MPXV
Days 1 and 43
Geometric Mean Concentration of Binding Antibodies (bAbs) Against MPXV Antigens by Meso Scale Discovery (MSD) Assay
Days 1, 29, 43, and 57
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
mRNA-1769 Dose AEXPERIMENTALParticipants will receive intramuscular (IM) injection of mRNA-1769 at Dose A on Day 1 and Day 29.
mRNA-1769 Dose BEXPERIMENTALParticipants will receive IM injection of mRNA-1769 at Dose B on Day 1 and Day 29.
mRNA-1769 Dose CEXPERIMENTALParticipants will receive IM injection of mRNA-1769 at Dose C on Day 1 and Day 29.
PlaceboPLACEBO_COMPARATORParticipants will receive IM injection of placebo matched to mRNA-1769 on Day 1 and Day 29.
Interventions
NameTypeDescription
mRNA-1769BIOLOGICALSterile liquid for injection
PlaceboOTHER0.9% sodium chloride injection (normal saline)
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Eligibility Criteria
Age Range18 Years — 49 Years
SexALL
Healthy VolunteersYes
Study Sites12

Inclusion Criteria: * Has a body mass index (BMI) between ≥18 kilogram per square meter (kg/m\^2) to ≤39 kg/m\^2. * For female participants of childbearing potential: must have a negative highly sensitive pregnancy test with 28 days before the first dose of study drug, uses approved contraception d...

Countries:United Kingdom
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