Recent Updates
Recently added Catalysts

VAL-339851

Phase 1

Influenza | Monoclonal antibody | Infectious Disease |Moderna, Inc.|Last Updated: Jan 11, 2021

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment156

FDA Designations

No designations recorded

Clinical trial landscape

VAL-339851 · 1 trial · 1 indication

Phase 1 1
NCT03345043Safety, Tolerability, and Immunogenicity of VAL-339851 in Healthy Adult SubjectsInfluenza
COMPLETED156 Analytics
PHASE1COMPLETED
Safety, Tolerability, and Immunogenicity of VAL-339851 in Healthy Adult Subjects
InfluenzaUnlock trial analytics

Study Endpoints

Primary Endpoints

Frequency of solicited AEs (local and systemic reactogenicity events)
7 days following each dose administration
Frequency of unsolicited adverse events
21 days following each dose administration
Frequency of serious adverse events (SAE), adverse events of special interest (AESI), medically-attended AEs, and new onset of chronic illness
One year after last dose administration

Secondary Endpoints

Titers of hemagglutinin inhibition (HAI) and microneutralization antibodies in comparison with baseline sample
One year after last dose administration
Seroconversion rates in comparison to baseline samples
One year after last dose administration
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
VAL-339851EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
VAL-339851BIOLOGICALEscalating dose levels
PlaceboOTHERSaline
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 49 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Agrees to comply with the study procedures and provides written informed consent * 18 to 49 years of age * Body mass index between 18 and 35 kg/m2 * Negative urine pregnancy test at the Screening visit and the day of each vaccination for females of childbearing potential. * Fe...

Countries:United States
Unlock Eligibility Criteria

Frequently asked questions about VAL-339851

What is VAL-339851 used for?

VAL-339851 is an investigational monoclonal antibody being developed for influenza. It is intended for use in the infectious disease therapeutic area. The drug is currently in Phase 1 clinical development and is not yet approved for any use.

Who makes VAL-339851?

VAL-339851 is being developed by Moderna, Inc., a biotechnology company traded on the NASDAQ under the ticker MRNA. The company is conducting clinical trials to evaluate the safety, tolerability, and immunogenicity of this investigational monoclonal antibody for influenza.

What phase is VAL-339851 in?

VAL-339851 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 drug remains in early-stage clinical development.

What clinical trials is VAL-339851 in?

VAL-339851 has one completed Phase 1 clinical trial, identified as NCT03345043. This study evaluated the safety, tolerability, and immunogenicity of VAL-339851 in healthy adult subjects in the United States. The trial enrolled 156 participants and was placebo-controlled, randomized, and double-blind.

Is VAL-339851 the same as another drug?

VAL-339851 is the primary name for this investigational monoclonal antibody. No alternative names have been identified for this drug in the available information. It is being studied specifically for its potential use in influenza.