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VYD2311

Phase 1

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

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_CONTROLLEDBiomarker
Total Trials1
Total Enrollment40
FDA Designations
FAST_TRACK
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06523153A Study of the Investigational Monoclonal Antibody, VYD2311, in Healthy ParticipantsPHASE1 ACTIVE NOT_RECRUITING 40 — — Aug 28, 2024May 1, 2025Nov 19, 20241 Australia
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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 — 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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Competitive Landscape -COVID-19 39 trials
CompanyTickerTrialsLead PhaseDrugs
Pfizer Inc.PFE10PHASE3ibuzatrelvir, remdesivir, nirmatrelvir, ritonavir, COVID-19 Vaccine
BioNTech SE Sponsored ADRBNTX3PHASE3BNT162b2, BNT162b2 Vaccine, Bivalent BNT162b2 3 microgram dose, Bivalent BNT162b2 6 microgram dose, Bivalent BNT162b2 10 microgram dose
Merck & Co., Inc.MRK1PHASE3Molnupiravir
Invivyd, Inc.IVVD2PHASE3VYD2311-SD, VYD2311-MD, VYD2311
Vanda Pharmaceuticals Inc.VNDA1PHASE3Tradipitant
BioVie Inc. Class ABIVI1PHASE2NE3107
ImmunityBio IncIBRX2PHASE2Anktiva, N-803
Traws Pharma, Inc.TRAW1PHASE2Ratutrelvir non-randomised, Paxlovid, Ratutrelvir
GeoVax Labs, Inc.GOVX1PHASE2COVID-19 Vaccine, Synthetic MVA-based SARS-CoV-2 Vaccine GEO-CM04S1
Unity Health TorontoUBX1PHASE3Paxlovid, Antioxidant
Moderna, Inc.MRNA1 — SPIKEVAX Bivalent BA.1, SPIKEVAX XBB.1.5, SPIKEVAX JN.1
Abbott LaboratoriesABT1NAUndisclosed
Design Therapeutics, Inc.DSGN1EARLY_PHASE1COVID-19 Therapeutic Biologic Mix - NOVAVAX COVID-19 VACCINE plus BCG Vaccine Mix for percutaneous use
Jade Biosciences, Inc.JBIO1NAUndisclosed
Structure Therapeutics, Inc. Sponsored ADRGPCR1NAUndisclosed
Co-Diagnostics, Inc.CODX1 — Undisclosed
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06523153primaryCompletionDate: changed
LOWMay 24, 2026NCT06523153studyFirstPostDate: changed