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AB-101

Phase 1

Chronic Hepatitis b | Small molecule | Infectious Disease |Arbutus Biopharma Corporation|Last Updated: Apr 13, 2026

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
RandomizedCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment128
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05960240Safety, Tolerability, PK & PD of AB-101 Following Oral Administration in Healthy and CHB Subjects.PHASE1 COMPLETED 128 — — Aug 30, 2023Feb 9, 2026Apr 13, 202610 Hong Kong, Italy +5
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Study Endpoints
Primary Endpoints
Parts 1 and 2: Incidence of adverse events (AEs), serious AEs (SAEs), immune related AEs (irAEs) and discontinuations due to AEs and irAEs.
[Time Frame: Up to 57 (Part 1) or 84 (Part 2) days]
Part 3: Incidence of AEs, SAEs, irAEs and discontinuations due to AEs and irAEs
[Time Frame: Up to 196 days]
Parts 1 and 2: Incidence of clinically significant laboratory abnormalities Parts 1 and 2: Incidence of clinically significant laboratory abnormalities
[Time Frame: Up to 57 (Part 1) or 84 (Part 2) days]
Parts 1 and 2: Incidence of clinically significant changes in vital signs (heart rate, blood pressure, temperature, respiratory rate), physical examinations and electrocardiograms (ECGs)
[Time Frame: Up to 57 (Part 1) or 84 (Part 2) days]
Part 3: Incidence of clinically significant laboratory abnormalities
[Time Frame: Up to 196 days]
Part 3: Incidence of clinically significant changes in vital signs (heart rate, blood pressure, temperature, respiratory rate), physical examinations and electrocardiograms (ECGs)
[Time Frame: Up to 196 days]
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part 1EXPERIMENTAL -
Part 2EXPERIMENTAL -
Part 3EXPERIMENTAL -
Interventions
NameTypeDescription
AB-101DRUGAB-101 is an oral small molecule PD-L1 checkpoint inhibitor being developed for the treatment of chronic infection with HBV in combination with other agents.
PlaceboDRUGA placebo is any treatment that has no active properties, such as a sugar pill. We will use matching placebo for this study.
Nucleos(t)ide AnalogueDRUGNucleos(t)ide analogues (NUCs) are the standard and mostly lifelong treatment for chronic HBeAg-negative hepatitis B.
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersYes
Study Sites10

Inclusion Criteria: Part 1 and 2 (Healthy Volunteers) * Male between ages 18-50 years * Willing and able to provide informed consent Willing to follow protocol-specified contraception requirement Inclusion Criteria: Part 3 (CHB Subjects) * Male or female subjects between the ages of 18-60 years ...

Countries:Hong KongItalyMoldovaNew ZealandRomaniaSingaporeUkraine
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Recent Changes (Last 90 Days)
MEDIUMMay 26, 2026NCT05960240TRIAL_REMOVED: changed
LOWMay 24, 2026NCT05960240studyFirstPostDate: changed