Can a new injection tame chronic hepatitis b?
NCT ID NCT07771140
First seen Aug 18, 2026 · Last updated Aug 19, 2026 · Updated 1 time
Summary
This early-stage trial is testing an investigational drug called HECN30227, given as an injection, in healthy volunteers and in people with chronic hepatitis B. The study aims to assess the drug's safety, how the body processes it, and its potential to reduce the virus. Participants receive either the drug or a placebo, with some receiving a single dose and others multiple doses.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HECN30227 injection
- What this could lead to
- If successful, this could lead to a new treatment option for chronic hepatitis B, potentially reducing or clearing the virus.
- What could go wrong
- This is an early-phase trial focused on safety and dosing, so it is too soon to know if the drug will be effective. Possible side effects are still being evaluated.
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 78 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Apr 2027
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: 1. Subjects must understand and comply with the study procedures, voluntarily participate, and sign the informed consent form. 2. Male subjects must weigh at least 50 kg; female subjects must weigh at least 45 kg. 3. Vital signs, physical examination, laboratory tests, electrocardiography (ECG), chest X-ray, and abdominal ultrasound (liver, gallbladder, spleen, pancreas, and both kidneys) are normal, or abnormalities are judged by the investigator to be clinically insignificant. 4. Female subjects of childbearing potential or male subjects must agree to use effective contraception from the time of signing the informed consent form until 6 months after the last dose of study drug. 5. Subjects must have received stable treatment with nucleos(t)ide analogues (NAs) (e.g., entecavir, tenofovir disoproxil fumarate, or tenofovir alafenamide) for at least 6 months prior to screening. 6. HBV DNA \< 90 IU/mL at screening. 7. HBsAg \> 100 IU/mL at screening. 8. Serum ALT and AST ≤ 2 × ULN, and total serum bilirubin ≤ 2 × ULN at screening and baseline. Exclusion Criteria: 1. Subjects who have undergone major surgery within 3 months prior to screening, or plan to undergo surgery during the study period. 2. Subjects with a history of allergy to the study drug or any of its components, or with allergic diathesis (allergic to two or more types of drugs or foods). 3. Subjects with a history of alcohol abuse within 1 year prior to screening , or those with a positive blood alcohol test result prior to dosing. 4. Subjects with a history of drug abuse or use of illicit drugs within 1 year prior to screening, or those with a positive urine drug screening result prior to dosing. 5. Subjects who donated blood ≥200 mL, or donated any blood component, or suffered a total blood loss ≥200 mL for any reason within 3 months prior to screening; or those with a history of blood transfusion or blood product administration. 6. Subjects who participated in another clinical trial within 3 months prior to screening. 7. Subjects who develop an acute illness (e.g., acute respiratory disease) or receive concomitant medication from the time of signing the informed consent form to prior to the first dose. 8. Subjects who are breastfeeding or have a positive serum pregnancy test result. 9. Subjects with significant hepatic fibrosis or liver cirrhosis. 10. Subjects with a history of hepatic decompensation manifestations or disease at screening or in the past, including but not limited to ruptured esophageal and gastric variceal bleeding, ascites, hepatic encephalopathy, etc. 11. Subjects diagnosed with any malignant tumor within 5 years prior to screening , or those assessed to have potential malignant tumors at present. 12. Subjects with international normalized ratio (INR) \>1.5, or platelet count \<90×10⁹/L, or serum albumin \<35 g/L at screening. 13. Subjects with alpha-fetoprotein (AFP) \>50 ng/mL at screening. 14. Subjects with endogenous creatinine clearance (CLcr) \<60 mL/min/1.73 m² at screening. 15. Subjects receiving, or who have received any interferon-containing regimen or immunosuppressive therapy within 1 year prior to screening. 16. Subjects whom the investigator considers unsuitable for participation in this trial for any other reasons.
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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 places running it
1 site. 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
Locations
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The Second Affiliated Hospital of Anhui Medical University
RECRUITINGHefei, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Massive french study to track virus effects on pregnant women and kids for 7 years
- New blood test could spot liver cancer sooner
- Scientists map liver degeneration at the cellular level
- New hope for hepatitis b patients with normal ALT: TMF drug trial underway
- 5000 hepatitis b patients to be tracked for immune clues