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New pill aims to tame chronic hepatitis b

NCT ID NCT05960240

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

128 people

The number who actually took part.

Started

Aug 2023

Finished

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

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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

  • ASST Papa Giovanni XXIII -Osepedale

    Bergamo, Italy

  • Clinial Republican Hospital "Timofei Mosneaga"

    Chisinau, Moldova

  • Clinical Republican Hospital "Timofei Mosneaga", ARENSIA E. M.

    Bucharest, Romania

  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

    Milan, Italy

  • Municipal Non-Profit Enterprise Kyiv City Clinical Hospital No12 Executive Body of Kyiv City Council

    Kyiv, Ukraine

  • National University Hospital

    Singapore, Singapore

  • New Zealand Clinical Research Auckland

    Grafton, Auckland, New Zealand

  • Prince of Wales Hospital

    Hong Kong, Hong Kong, Hong Kong

  • Queen Mary Hospital - PPDS

    Hong Kong, Hong Kong, Hong Kong

  • Singapore General Hospital

    Singapore, Singapore

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