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Vebicorvir

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment6

FDA Designations

No designations recorded

Clinical trial landscape

Vebicorvir · 1 trial · 1 indication

Phase 1 1
NCT04637139A Study to Evaluate the Mass Balance Absorption and AME of VBRChronic Hepatitis B
COMPLETED6 Analytics
PHASE1COMPLETED
A Study to Evaluate the Mass Balance Absorption and AME of VBR
Chronic Hepatitis BUnlock trial analytics

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 to 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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Frequently asked questions about Vebicorvir

What is Vebicorvir used for?

Vebicorvir is an investigational small molecule being developed for the treatment of chronic Hepatitis B. It is currently in Phase 1 clinical development and has not been approved by the FDA. The drug is being studied to evaluate its absorption and metabolism in the body.

Who makes Vebicorvir?

Vebicorvir is being developed by Assembly Biosciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol ASMB. The company is conducting clinical research on this investigational drug for chronic Hepatitis B.

What phase is Vebicorvir in?

Vebicorvir is currently in Phase 1 clinical development. It is an investigational drug and has not yet received FDA approval. The drug is being studied for the treatment of chronic Hepatitis B, and its safety and pharmacokinetics are being evaluated in early-stage trials.

What clinical trials is Vebicorvir in?

Vebicorvir has one completed Phase 1 clinical trial registered under NCT04637139. This study evaluated the mass balance absorption and metabolism of Vebicorvir in healthy male volunteers. The trial enrolled 6 participants and was conducted in the United States.

Is Vebicorvir FDA approved?

No, Vebicorvir is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for chronic Hepatitis B. The drug has not completed the clinical trials necessary to establish its safety and efficacy for regulatory approval.