Chronic Hepatitis bPhase 1NCT05960240
Safety, Tolerability, PK & PD of AB-101 Following Oral Administration in Healthy and CHB Subjects.
A Phase 1 study testing AB-101 and Nucleos(t)ide Analogue in people with Chronic Hepatitis b, run by Arbutus Biopharma Corporation at 10 sites in 7 countries.
Trial summary
This three-part, Phase 1 protocol will be the first clinical study of AB-101. Parts 1 and 2 will be a Phase 1a SAD/MAD of AB-101 in healthy adult subjects. Part 3 will be a Phase 1b dose-ranging assessment of AB-101 in non-cirrhotic Chronic Hepatitis B (CHB) subjects. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Hepatitis b
- What is being tested?
- AB-101 and Nucleos(t)ide Analogue
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 10 sitesin 7 countries
- Study dates
- 30 Aug 2023to 9 Feb 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male between ages 18-50 years
- Willing and able to provide informed consent
- Willing to follow protocol-specified contraception requirement
- Male or female subjects between the ages of 18-60 years
- Willing to provide informed consent
- Chronic HBV infection for at least 6 months
- Willing to follow protocol-specified contraception requirement
Who cannot join
- Clinically significant lab abnormalities
- A history of clinically significant gastrointestinal, hematologic, renal, hepatic, bronchopulmonary, neurological, psychiatric, cardiovascular, autoimmune or other immune-mediated disease.
- HIV or Hep C positive
- Known chronic or severe infection or recent significant exposure to infections such as tuberculosis or endemic mycosis, untreated latent infections like tuberculosis, or a positive or indeterminate QuantiFERON test.
- Have extensive fibrosis or cirrhosis of the liver
- Have or had liver cancer (hepatocellular carcinoma)
Show all 9Show fewer
- Have a history or current autoimmune disease or has been on immunosuppressive medications within 6 months of the start of the study
- Females who breastfeeding, pregnant or who wish to become pregnant during the study
- Known chronic or severe infection or recent significant exposure to infections such as tuberculosis or endemic mycosis, untreated latent infections like tuberculosis, or a positive or indeterminate QuantiFERON test.
Trial locations and contacts
10 sites in 7 countries.
10 sites in 7 countries
Hong Kong2 sites
Prince of Wales Hospital
Hong Kong, Hong Kong
Queen Mary Hospital - PPDS
Hong Kong, Hong Kong
Italy2 sites
ASST Papa Giovanni XXIII -Osepedale
Bergamo
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan
Singapore2 sites
National University Hospital
Singapore
Singapore General Hospital
Singapore
New Zealand1 site
New Zealand Clinical Research Auckland
Grafton, Auckland
Romania1 site
Clinical Republican Hospital "Timofei Mosneaga", ARENSIA E. M.
Bucharest
Ukraine1 site
Municipal Non-Profit Enterprise Kyiv City Clinical Hospital No12 Executive Body of Kyiv City Council
Kyiv
About this study
Official title: A Double-Blind, Randomized, Placebo-Controlled, Single and Multiple Dose Study Evaluating the Safety, Tolerability, PK and PD of AB-101, an Oral PD-L1 Inhibitor, in Healthy Subjects and Subjects With Chronic HBV Infection.
This three-part, Phase 1 protocol will be the first clinical study of AB-101. Parts 1 and 2 will be a Phase 1a SAD/MAD of AB-101 in healthy adult subjects.
Part 3 will be a Phase 1b dose-ranging assessment of AB-101 in non-cirrhotic Chronic Hepatitis B (CHB) subjects.
- Conditions
- Chronic Hepatitis b
- Being tested
- AB-101, Placebo, Nucleos(t)ide Analogue
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AB-101Drug
AB-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.
PlaceboDrug
A 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 AnalogueDrug
Nucleos(t)ide analogues (NUCs) are the standard and mostly lifelong treatment for chronic HBeAg-negative hepatitis B.
| Study group | Role | What they receive |
|---|---|---|
| Part 1 | Experimental | Not described Receives: Drug: AB-101; Drug: Placebo |
| Part 2 | Experimental | Not described Receives: Drug: AB-101; Drug: Placebo |
| Part 3 | Experimental | Not described Receives: Drug: AB-101; Drug: Placebo; Drug: Nucleos(t)ide Analogue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parts 1 and 2: Incidence of adverse events (AEs), serious AEs (SAEs), immune related AEs (irAEs) and discontinuations due to AEs and irAEs.
Measured: [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
Measured: [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
Measured: [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)
Measured: [Time Frame: Up to 57 (Part 1) or 84 (Part 2) days]
Part 3: Incidence of clinically significant laboratory abnormalities
Measured: [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)
Measured: [Time Frame: Up to 196 days]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2023
- Study start30 Aug 2023
- Primary completion4 Dec 2025
- Study completion9 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis bStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arbutus Biopharma Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05960240
- Sponsor's protocol ID
- AB-101-001
- Status last verified
- Apr 2026
- First submitted
- 14 Jul 2023
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Placebo-Controlled, Single and Multiple Dose Study Evaluating the Safety, Tolerability, PK and PD of AB-101, an Oral PD-L1 Inhibitor, in Healthy Subjects and Subjects With Chronic HBV Infection.
- ClinicalTrials.gov ID
- NCT05960240
- Acronym / sponsor ID
- AB-101-001
- Conditions
- Chronic Hepatitis b
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Arbutus Biopharma CorporationIndustry (pharma, biotech, devices)
- Study start
- 30 Aug 2023 (actual)
- Primary completion
- 4 Dec 2025 (actual)
- Study completion
- 9 Feb 2026 (actual)
- First posted
- 25 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This three-part, Phase 1 protocol will be the first clinical study of AB-101. Parts 1 and 2 will be a Phase 1a SAD/MAD of AB-101 in healthy adult subjects.
Part 3 will be a Phase 1b dose-ranging assessment of AB-101 in non-cirrhotic Chronic Hepatitis B (CHB) subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1 | Experimental | Drug: AB-101, Drug: Placebo |
| Part 2 | Experimental | Drug: AB-101, Drug: Placebo |
| Part 3 | Experimental | Drug: AB-101, Drug: Placebo, Drug: Nucleos(t)ide Analogue |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male between ages 18-50 years
- Willing and able to provide informed consent
- Willing to follow protocol-specified contraception requirement
- Male or female subjects between the ages of 18-60 years
- Willing to provide informed consent
Key exclusion criteria (9 listed)
- Clinically significant lab abnormalities
- A history of clinically significant gastrointestinal, hematologic, renal, hepatic, bronchopulmonary, neurological, psychiatric, cardiovascular, autoimmune or other immune-mediated disease.
- HIV or Hep C positive
- Known chronic or severe infection or recent significant exposure to infections such as tuberculosis or endemic mycosis, untreated latent infections like tuberculosis, or a positive or indeterminate QuantiFERON test.
- Have extensive fibrosis or cirrhosis of the liver
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AB-101AB-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. | Drug | Part 1, Part 2, Part 3 |
| PlaceboA placebo is any treatment that has no active properties, such as a sugar pill. We will use matching placebo for this study. | Drug | Part 1, Part 2, Part 3 |
| Nucleos(t)ide AnalogueNucleos(t)ide analogues (NUCs) are the standard and mostly lifelong treatment for chronic HBeAg-negative hepatitis B. | Drug | Part 3 |
Primary outcome
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: [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: [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: [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: [Time Frame: Up to 57 (Part 1) or 84 (Part 2) days]
Part 3: Incidence of clinically significant laboratory abnormalities
Time frame: [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: [Time Frame: Up to 196 days]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AB-101 and Nucleos(t)ide Analogue in people with Chronic Hepatitis b, run by Arbutus Biopharma Corporation at 10 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Hong Kong, Italy, Singapore, Moldova, New Zealand and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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: [Time Frame: Up to 57 (Part 1) or 84 (Part 2) days]). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.