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mRNA-1944

Phase 1

Prevention of Chikungunya Virus Infection | Monoclonal antibody | Other |Moderna, Inc.|Last Updated: Jul 7, 2021

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 Enrollment39
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03829384Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of mRNA-1944 in Healthy AdultsPHASE1 COMPLETED 39Jan 22, 2019Jun 7, 2021Jul 7, 20211 United States
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Study Endpoints
Primary Endpoints
Frequency of adverse events (AEs), serious adverse events (SAEs), adverse events of special interest (AESI) and laboratory abnormalities
Through 13 months of study participation
Secondary Endpoints
Area under the concentration versus time curve (AUC)
Baseline through 28 days post dose
Maximum observed serum concentration (Cmax) after administration of mRNA-1944
Baseline through 28 days post dose
Time of Cmax (tmax)
Baseline through 28 days post dose
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
mRNA-1944EXPERIMENTALEscalating dose levels
PlaceboPLACEBO_COMPARATORSaline
Interventions
NameTypeDescription
mRNA-1944BIOLOGICALmRNA encoding Chikungunya antibody
PlaceboOTHERSaline
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Eligibility Criteria
Age Range18 Years — 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male or female ≥ 18 and ≤ 50 years of age * Weight of 50 to 100 kg, inclusive * In good general health as determined by medical history, clinical laboratory assessments, ECG results, vital sign measurements, and physical examination findings at screening * Has access to consis...

Countries:United States
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