Recent Updates
Recently added Catalysts

VIR-3434

Phase 1

Chronic Hepatitis B | Monoclonal antibody | Infectious Disease |Vir Biotechnology, Inc.|Last Updated: Oct 8, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment113
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04423393Study of VIR-3434 in Healthy Volunteers and Patients With Chronic Hepatitis B Virus InfectionPHASE1 COMPLETED 113 — — May 26, 2020Nov 25, 2022Oct 8, 202424 Germany, Hong Kong +5
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
Number of Participants With Clinical Laboratory Abnormalities
Up to 280 days post-dose
Secondary Endpoints
Cmax
Parts B-D: pre-dose and 1, 4, 6, 24 hours, 3, 7, 10, 14, 28, 56, 84, 112, 168, 224, 280 days post-dose
Tmax
Part A: pre-dose and 1, 4, 6, 24 hours, 3, 7, 14, 28, 56, 84, 126, 168 days post-dose; Parts B-D: pre-dose and 1, 4, 6, 24 hours, 3, 7, 10, 14, 28, 56, 84, 112, 168, 224, 280 days post-dose
AUClast
Parts B-D: pre-dose and 1, 4, 6, 24 hours, 3, 7, 10, 14, 28, 56, 84, 112, 168, 224, 280 days post-dose
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
VIR-3434EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
VIR-3434BIOLOGICALVIR-3434 given by subcutaneous injection or intravenous infusion.
PlaceboOTHERSterile normal saline (0.9% NaCl) given by subcutaneous injection or intravenous infusion.
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites24

Healthy Volunteers: Inclusion Criteria: * Male or female age 18 - 55 * Weight 40-125 kg Exclusion Criteria: * Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation * History or evidence of drug or alcohol abuse * History of allergic r...

Countries:GermanyHong KongNew ZealandRomaniaSingaporeSouth KoreaUnited Kingdom
Unlock Eligibility Criteria