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VYD2311

Phase 1

COVID-19 | Monoclonal antibody | Infectious Disease |Invivyd, Inc.|Last Updated: Nov 19, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment40

FDA Designations

FAST_TRACK

Clinical trial landscape

VYD2311 · 1 trial · 1 indication

Phase 1 1
NCT06523153A Study of the Investigational Monoclonal Antibody, VYD2311, in Healthy ParticipantsCOVID-19
ACTIVE NOT_RECRUITING40 Analytics
PHASE1ACTIVE NOT_RECRUITING
A Study of the Investigational Monoclonal Antibody, VYD2311, in Healthy Participants
COVID-19Unlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of TEAEs (including AEs and SAEs)
Through Month-6 visit

Secondary Endpoints

PK parameter of VYD2311, AUC0-inf (area under the concentration-time curve from time 0 extrapolated to infinity)
Through Month-6 visit
PK parameter of VYD2311, AUClast (area under the concentration-time curve from time 0 to the last quantifiable concentration)
Through Month-6 visit
PK parameter of VYD2311, AUC0-t (area under the concentration-time curve from time 0 to t)
Through Month-6 visit
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeOTHER

Treatment Arms

ArmTypeDescription
VYD2311EXPERIMENTALInjection in healthy volunteer
PlaceboPLACEBO_COMPARATORInjection in healthy volunteer

Interventions

NameTypeDescription
VYD2311BIOLOGICALMonoclonal antibody
PlaceboOTHERMatching Placebo
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Is a male or female participant aged 18 to 65 years, inclusive. * Has a body mass index 18.0 to 32.0 kg/m2, inclusive. * Is in good health, with no clinically significant abnormalities as determined by the Investigator based on medical history, physical exam, vital signs, ECG,...

Countries:Australia
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Frequently asked questions about VYD2311

What is VYD2311 used for?

VYD2311 is an investigational monoclonal antibody being developed for COVID-19. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied for its potential to prevent or treat COVID-19, though its exact use is still under investigation.

What does VYD2311 target?

VYD2311 is a monoclonal antibody designed to target SARS-CoV-2, the virus that causes COVID-19. As an antibody, it is intended to bind to the virus and neutralize it, potentially reducing the severity of infection. However, the specific viral protein it targets has not been disclosed.

Who is developing VYD2311?

VYD2311 is being developed by Invivyd, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol IVVD. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational monoclonal antibody for COVID-19.

What phase is VYD2311 in?

VYD2311 is currently in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The Phase 1 trial is designed to assess the safety, tolerability, and pharmacokinetics of the drug in healthy participants.

What clinical trials is VYD2311 in?

VYD2311 is being evaluated in a Phase 1 clinical trial with the identifier NCT06523153. This randomized, double-blind, placebo-controlled study is enrolling 40 healthy participants in Australia. The trial is active but not currently recruiting, and it is designed to assess the safety and tolerability of VYD2311.

Is VYD2311 the same as any other drug?

VYD2311 is a distinct investigational monoclonal antibody developed by Invivyd, Inc. There are no alternative names provided for this drug. It is not the same as any other approved or investigational drug, and it is being studied specifically for its potential use in COVID-19.