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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

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDDMC
Total Trials1
Total Enrollment128

FDA Designations

No designations recorded

Clinical trial landscape

AB-101 · 1 trial · 1 indication

Phase 1 1
NCT05960240Safety, Tolerability, PK & PD of AB-101 Following Oral Administration in Healthy and CHB Subjects.Chronic Hepatitis b
COMPLETED128 Analytics
PHASE1COMPLETED
Safety, Tolerability, PK & PD of AB-101 Following Oral Administration in Healthy and CHB Subjects.
Chronic Hepatitis bUnlock trial analytics

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 to 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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Frequently asked questions about AB-101

What is AB-101 used for?

AB-101 is an investigational small molecule being developed for the treatment of chronic hepatitis B. It is currently in Phase 1 clinical development and has been studied in healthy volunteers and subjects with chronic hepatitis B.

Who is developing AB-101?

AB-101 is being developed by Arbutus Biopharma Corporation, a biopharmaceutical company traded on the NASDAQ under the ticker symbol ABUS.

What phase is AB-101 in?

AB-101 is in Phase 1 clinical development. A Phase 1 trial evaluating its safety, tolerability, pharmacokinetics, and pharmacodynamics has been completed.

What clinical trials is AB-101 in?

AB-101 has been studied in a Phase 1 clinical trial registered as NCT05960240. This trial assessed the safety, tolerability, pharmacokinetics, and pharmacodynamics of AB-101 following oral administration in healthy subjects and subjects with chronic hepatitis B.

Is AB-101 the same as any other drug?

AB-101 is the investigational name used by Arbutus Biopharma for this small molecule candidate. No alternative names have been reported for this drug.