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Vebicorvir

Phase 1

Chronic Hepatitis B | Small molecule | Infectious Disease |Assembly Biosciences, Inc.|Last Updated: Jan 12, 2021

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment6
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04637139A Study to Evaluate the Mass Balance Absorption and AME of VBRPHASE1 COMPLETED 6 — — Dec 1, 2020Dec 22, 2020Jan 12, 20211 United States
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Study Endpoints
Primary Endpoints
Mass Balance: Cumulative Amount of [14C] Radiolabel Excreted in Urine up to the Last Sampling Interval (Ae-urine, 14C)
Before dosing and at prespecified time intervals up to 168 hours after dosing
Mass Balance: Cumulative Amount of [14C] Radiolabel Excreted in Feces up to the Last Sampling Interval (Ae-feces, 14C)
Before dosing and at prespecified time intervals up to 168 hours after dosing
Secondary Endpoints
Number of Participants with One or More Adverse Events
Up to 168 hours
Number of Participants Discontinued from the Study Due to an Adverse Event
Up to 168 hours
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Group 1EXPERIMENTALVBR 300 mg solution containing 2 µCi \[14C\]VBR
Interventions
NameTypeDescription
Vebicorvir (VBR)DRUG300mg Vebicovir containing 2 µCi \[14C\]VBR.
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Eligibility Criteria
Age Range18 Years — 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

* Consent * Male between 18 and 55 years of age (inclusive) at the time of Screening * Body mass index (BMI) between ≥18.0 kg/m2 and ≤32.0 kg/m2 at Screening; body weight between ≥55.0 kg and ≤100.0 kg at Screening * Considered to be in good health by the Investigator Exclusion Criteria: * History...

Countries:United States
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