New pill aims to tame chronic hepatitis b
NCT ID NCT05960240
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage trial tests AB-101, an oral drug that blocks a protein called PD-L1 to help the immune system fight the hepatitis B virus. The study involves 128 people, including healthy volunteers and patients with chronic hepatitis B. Researchers are primarily checking for safety and how the body processes the drug.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- AB-101 (an oral PD-L1 inhibitor)
- What this could lead to
- If successful, this could lead to a new treatment option for chronic hepatitis B, potentially reducing the need for lifelong medication.
- What could go wrong
- This is an early Phase 1 trial focused on safety, not effectiveness. The drug may cause immune-related side effects and may not work as hoped.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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128 people
The number who actually took part.
- Started
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Aug 2023
- Finished
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Feb 2026
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 * Willing to provide informed consent * Chronic HBV infection for at least 6 months * Willing to follow protocol-specified contraception requirement Exclusion Criteria: Part 1 and 2 (Healthy Volunteers) Key Exclusion Criteria: * 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. Exclusion Criteria: Part 3 (CHB Subjects) * Have extensive fibrosis or cirrhosis of the liver * Have or had liver cancer (hepatocellular carcinoma) * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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ASST Papa Giovanni XXIII -Osepedale
Bergamo, Italy
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Clinial Republican Hospital "Timofei Mosneaga"
Chisinau, Moldova
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Clinical Republican Hospital "Timofei Mosneaga", ARENSIA E. M.
Bucharest, Romania
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Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan, Italy
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Municipal Non-Profit Enterprise Kyiv City Clinical Hospital No12 Executive Body of Kyiv City Council
Kyiv, Ukraine
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National University Hospital
Singapore, Singapore
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New Zealand Clinical Research Auckland
Grafton, Auckland, New Zealand
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Prince of Wales Hospital
Hong Kong, Hong Kong, Hong Kong
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Queen Mary Hospital - PPDS
Hong Kong, Hong Kong, Hong Kong
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Singapore General Hospital
Singapore, Singapore
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Other studies related to the condition(s) this trial covers.
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