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ABI-H3733

Phase 1

Chronic Hepatitis B | Small molecule | Infectious Disease |Assembly Biosciences, Inc.|Last Updated: Jun 29, 2023

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_CONTROLLED
Total Trials1
Total Enrollment31
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05414981A Study to Assess the Safety, Pharmacokinetics, and Antiviral Activity of ABI-H3733 in Subjects With Chronic Hepatitis B Virus InfectionPHASE1 COMPLETED 31Aug 7, 2022Apr 24, 2023Jun 29, 20239 Bulgaria, Hong Kong +4
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Study Endpoints
Primary Endpoints
Proportion of subjects with adverse events (AEs), premature treatment discontinuation due to AEs, and abnormal laboratory results
Through end of study, up to 56 days
Secondary Endpoints
Maximum Plasma Concentration (Cmax) of ABI-H3733 in subjects with cHBV
Through treatment period, up to 28 days
Minimum Plasma Concentration (Cmin) of ABI-H3733 in subjects with cHBV
Through treatment period, up to 28 days
Area Under Plasma Concentration-Time Curve (AUC) of ABI-H3733 in subjects with cHBV
Through treatment period, up to 28 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ABI-H3733ACTIVE_COMPARATOR -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
ABI-H3733DRUG25 mg or 100 mg tablets for oral administration
PlaceboDRUG25 mg or 100 mg tablets for oral administration
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: 1. Body mass index (BMI) ≥ 18.0 and \< 35.0 kg/m(2), where BMI = weight (kg)/(height \[m\])(2) with a minimum body weight of 45 kg. 2. Chronic hepatitis B infection, defined as HBV infection for ≥6 months documented 3. Treatment-naïve or off-antiviral therapy for ≥24 weeks prior...

Countries:BulgariaHong KongMoldovaNew ZealandRomaniaSingapore
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