New shot for hepatitis b heads into early safety testing
NCT ID NCT07600788
First seen Jun 25, 2026 · Last updated Jul 30, 2026 · Updated 3 times
Summary
This early-stage study tests a single injection of AHB-137 in 32 people with chronic hepatitis B, some with mild to moderate liver dysfunction and some with normal liver function. Researchers will measure how the drug moves through the body and check for safety issues. The goal is to understand how liver problems affect the drug, not yet to see if it works.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- AHB-137 injection
- What this could lead to
- If successful, this could help determine safe dosing for people with liver problems, moving toward a treatment for chronic hepatitis B.
- What could go wrong
- This is a very early Phase 1 study with only 32 participants, focused on safety and drug levels, not effectiveness. It may not lead to a working treatment.
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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About 32 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2026
- Expected to finish
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May 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 65 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: * Voluntarily participate in the study, sign an informed consent form before the study and be able to complete the study according to the requirements of the protocol; * At the time of signing the informed consent form, male or female participants aged 18-65 years (including threshold values); * Body mass index meets the criteria; * Take effective contraceptive measures as required; * Participants with liver function impairment need to meet certain liver function assessments; * Participants with normal liver function should meet certain age, weight, and gender requirements to match those with liver function impairment, and should also undergo certain physical and laboratory tests. Exclusion Criteria: * Diagnosed or suspected liver cancer participants who have undergone liver transplantation; * History of vasculitis or presence of signs and symptoms of potential vasculitis or laboratory tests; * Unstable control of hypertension or diabetes, progressive nervous system disease, history of immune related extrahepatic diseases, and unstable cardiac function; * Participants with a history of malignant tumors or undergoing malignant tumor assessment; * Screening for participants who have undergone significant trauma or surgery within the previous 3 months, as well as those who plan to undergo surgery; * Participants with thyroid dysfunction who are not suitable for inclusion in the study; * Allergic or allergic constitution to AHB-137; * Long term regular receipt of anticoagulant or antiplatelet drugs is required; * Those who have received any antisense oligonucleotide drugs or have been treated with siRNA drugs or interferon within the 12 months prior to screening; * Currently using or using any immunosuppressive medication within the past 3 months prior to screening, except for short-term use or the use of topical/inhaled steroids; Individuals who have used immunomodulators and cytotoxic drugs within the 6 months prior to administration; * Those who have a history of vaccination or a plan to receive live vaccines within one month before administration, those who have used creatine containing fitness supplements 14 days before administration, and those who have used albumin 14 days before administration; * HIV, Syphilis positive ; * Those who are participating in another clinical trial and have not been eluted as required; * Positive results in urine drug screening and alcohol breath screening tests during screening; * Those who drink excessively and consume prohibited foods and beverages before administration; * Participants who have donated blood (or lost blood) ≥ 400 ml, received whole blood, or used red blood cell suspension within the past 3 months prior to screening; Individuals with a history of needle or blood dizziness, difficulty in blood collection, or intolerance to venipuncture blood collection; * Long term regular vigorous exercise or intense exercise within 48 hours before screening; * Any other circumstances or conditions that the researcher deems unsuitable for the subject to participate in this study; * Diseases that need to be excluded according to the merger plan for patients with abnormal liver function; * The laboratory test results do not meet the requirements of the protocol; * Participants with normal liver function who have a history of chronic liver disease or known liver or biliary abnormalities; * Participants with normal liver function who have used traditional Chinese medicine or other systemic medications with potential liver toxicity 14 days before administration; * Participants with normal liver function and abnormal QTcF values.
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Genom att skicka in godkänner du våra Användarvillkor
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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
5 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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AusperBio Investigational Site
NOT_YET_RECRUITINGChongqing, Chongqing Municipality, China
Contact Email: •••••@•••••
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AusperBio Investigational Site
NOT_YET_RECRUITINGZhengzhou, Henan, China
Contact Email: •••••@•••••
Contact Email: •••••@•••••
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AusperBio Investigational Site
NOT_YET_RECRUITINGChengdu, Sichuan, China
Contact Email: •••••@•••••
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AusperBio Investigational Site
NOT_YET_RECRUITINGHangzhou, Zhejiang, China
Contact Email: •••••@•••••
Contact Email: •••••@•••••
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Huashan Hospital Fudan University
RECRUITINGShanghai, Shanghai Municipality, China
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