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mRNA-1944

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment39

FDA Designations

No designations recorded

Clinical trial landscape

mRNA-1944 · 1 trial · 1 indication

Phase 1 1
NCT03829384Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of mRNA-1944 in Healthy AdultsPrevention of Chikungunya Virus Infection
COMPLETED39 Analytics
PHASE1COMPLETED
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of mRNA-1944 in Healthy Adults
Prevention of Chikungunya Virus InfectionUnlock trial analytics

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 to 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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Frequently asked questions about mRNA-1944

What is mRNA-1944 used for?

mRNA-1944 is an investigational messenger RNA (mRNA) therapeutic being developed for the prevention of Chikungunya virus infection. It is designed to encode a monoclonal antibody that targets the virus, though it is not yet approved and remains in clinical development.

Who makes mRNA-1944?

mRNA-1944 is being developed by Moderna, Inc., a biotechnology company publicly traded under the ticker symbol MRNA on the Nasdaq stock exchange. The company is conducting clinical research on this investigational mRNA-based monoclonal antibody candidate.

What phase is mRNA-1944 in?

mRNA-1944 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the candidate remains under evaluation for the prevention of Chikungunya virus infection.

What clinical trials is mRNA-1944 in?

mRNA-1944 has one completed Phase 1 clinical trial, identified as NCT03829384. The study, titled 'Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of mRNA-1944 in Healthy Adults,' enrolled 39 participants in the United States and evaluated the drug in healthy volunteers.

How does mRNA-1944 work?

mRNA-1944 is an mRNA-based monoclonal antibody therapy. It works by instructing cells to produce a monoclonal antibody that targets the Chikungunya virus, potentially providing protection against infection. This mechanism is based on the drug's design as an mRNA-encoded antibody.

Is mRNA-1944 the same as a traditional vaccine?

No, mRNA-1944 is not a traditional vaccine. It is an mRNA-encoded monoclonal antibody designed to deliver pre-formed antibodies for the prevention of Chikungunya virus infection, rather than stimulating the immune system to produce its own antibodies like a conventional vaccine.