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NDV-3A

Phase 2

Staphylococcus Aureus | Monoclonal antibody | Infectious Disease |cbdMD, Inc.|Last Updated: Jan 29, 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment382

FDA Designations

No designations recorded

Clinical trial landscape

NDV-3A · 1 trial · 1 indication

Phase 2 1
NCT03455309Evaluation of NDV-3A Vaccine in Preventing S. Aureus ColonizationStaphylococcus Aureus
COMPLETED382 Analytics
PHASE2COMPLETED
Evaluation of NDV-3A Vaccine in Preventing S. Aureus Colonization
Staphylococcus AureusUnlock trial analytics

Study Endpoints

Primary Endpoints

Prevent acquisition of incident Staphylococcus aureus nasal colonization
56 days post-vaccination

Change in incident Staphylococcus aureus nasal colonization by study day 56 in a population of US Army trainees at Ft. Benning, GA

Secondary Endpoints

Evaluation of the efficacy of the NDV-3A vaccine
0-90 days
Evaluation of safety and tolerability in all subjects
0-7 days
Measurement and characterization of immunogenicity of NDV-3A
0-90 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
NDV-3AACTIVE_COMPARATOR0.5 mL dose containing 300 micrograms of recombinant Als3 protein in phosphate-buffered saline and 0.5 mg aluminum as aluminum hydroxide
PlaceboPLACEBO_COMPARATOR0.5 mL dose containing phosphate-buffered saline and 0.5 mg aluminum as aluminum hydroxide

Interventions

NameTypeDescription
NDV-3ABIOLOGICALSingle dose administered by intramuscular injection
PlaceboBIOLOGICALSingle dose administered by intramuscular injection
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Eligibility Criteria

Age Range17 Years to 35 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Active duty, male subject, 17-35 years of age, inclusive, at the time of screening. * Assigned to one of the selected companies/battalions * Informed of the nature of the study and has agreed to and is able to read, review, and sign the informed consent document prior to scree...

Countries:United States
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Frequently asked questions about NDV-3A

What is NDV-3A used for?

NDV-3A is an investigational monoclonal antibody being developed for the prevention of Staphylococcus aureus colonization. It is intended for use in infectious disease, specifically targeting S. aureus. The drug is currently in Phase 2 clinical development and has not been approved by regulatory authorities.

What does NDV-3A target?

NDV-3A targets Staphylococcus aureus, a bacterium that can cause serious infections. As a monoclonal antibody, it is designed to prevent S. aureus colonization, which is the first step in establishing an infection. The drug is being studied for its ability to reduce the presence of this pathogen in at-risk individuals.

Who is developing NDV-3A?

NDV-3A is being developed by cbdMD, Inc., a company traded on the stock exchange under the ticker symbol YCBD. The company is conducting clinical research to evaluate the safety and efficacy of this investigational drug for preventing Staphylococcus aureus colonization.

What phase is NDV-3A in?

NDV-3A is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The drug is being studied for its potential to prevent Staphylococcus aureus colonization, and its safety and efficacy are still being evaluated in clinical trials.

What clinical trials is NDV-3A in?

NDV-3A has been studied in one completed Phase 2 clinical trial with the identifier NCT03455309. This trial, titled 'Evaluation of NDV-3A Vaccine in Preventing S. Aureus Colonization,' enrolled 382 participants in the United States. The study was randomized, double-blind, and placebo-controlled, and included healthy male volunteers aged 17 years and older.