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New treatment option for Hepatitis B, Chronic (CHB)
Official title Study of AHB-171 in Chronic Hepatitis B Participants
ClinicalTrials.gov ID: NCT07630727
What this study is testing
What is AHB-171 Injection?
AHB-171 Injection is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for hepatitis b, chronic (chb).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study adopts an open-label, multiple-dose design and aims to evaluate the efficacy and safety of AHB-171 Injection after multiple doses in treatment-naïve (HBeAg-negative/positive) and nucleos(t)ide analogue (NA)-treated (HBeAg-negative) participants with chronic hepatitis B (CHB)
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Able to fully understand and sign the informed consent form (ICF).
- Male or female participants, aged 18-65 years (inclusive).
- Body mass index (BMI) meeting the predefined eligibility range.
- Chronic hepatitis B (CHB) participants with HBsAg or HBV DNA positivity for ≥6 months at screening.
- At screening, participants meeting predefined ranges of HBsAg, HBV DNA, and ALT according to prior nucleos(t)ide analogue (NA) treatment history...
You likely can't join if
- History of any severe systemic disease or malignancy other than chronic HBV infection which, in the opinion of the investigator, makes the subject...
- Prior history of solid organ or hematopoietic stem cell transplantation.
- History of any other liver disease that the investigator considers unsuitable for trial.History of autoimmune disease or diseases with potential...
- History or presence of hepatic decompensation at screening.
- History of primary liver cancer, or diagnosis/suspected liver cancer at screening.
- Imaging or histological evidence of significant liver fibrosis or cirrhosis within 12 months prior to screening, or a liver stiffness measurement...
See the full eligibility criteria
- Able to fully understand and sign the informed consent form (ICF).
- Male or female participants, aged 18-65 years (inclusive).
- Body mass index (BMI) meeting the predefined eligibility range.
- Chronic hepatitis B (CHB) participants with HBsAg or HBV DNA positivity for ≥6 months at screening.
- At screening, participants meeting predefined ranges of HBsAg, HBV DNA, and ALT according to prior nucleos(t)ide analogue (NA) treatment history (stable prior treatment or treatment-naive), and meeting corresponding...
- Adopt effective contraceptive measures as required
- History of any severe systemic disease or malignancy other than chronic HBV infection which, in the opinion of the investigator, makes the subject unsuitable for study participation.
- Prior history of solid organ or hematopoietic stem cell transplantation.
- History of any other liver disease that the investigator considers unsuitable for trial.History of autoimmune disease or diseases with potential immune activation risk.
- History or presence of hepatic decompensation at screening.
- History of primary liver cancer, or diagnosis/suspected liver cancer at screening.
- Imaging or histological evidence of significant liver fibrosis or cirrhosis within 12 months prior to screening, or a liver stiffness measurement indicative of significant fibrosis or cirrhosis at screening. Major...
- History of severe allergies (e.g., to ≥2 allergens) or severe allergy to any component of the study drug, or in the opinion of the investigator, makes the subject unsuitable for participation.
- Severe infection requiring intravenous anti-infective therapy within 2 weeks prior to screening (excluding chronic HBV infection).
- History of drug abuse, or alcoholism.
- Blood donation or blood loss exceeding the specified volume within 12 weeks prior to screening, or planned blood donation during the trial period.
- Use of immunosuppressants, immunomodulators, cytotoxic drugs, or biologics within 6 months prior to screening.
- Use of any oligonucleotide drugs or interferon therapy within 12 months prior to screening.
- Vaccination within 4 weeks prior to screening, or planned vaccination during the trial period.
- Presence of tattoos, active skin diseases, or other conditions that may interfere with subcutaneous drug administration or observation of injection site reactions.
- Clinically significant abnormal electrocardiogram (ECG) at screening.
- Tested positive for HIV，HCV or active syphilis infection.
- Uncontrolled hypertension at screening.
- Clinically significant abnormal laboratory test as specified in protocol at screening.
- Currently participating in another clinical trials, or within the washout period.
- Any other condition or factor which, in the opinion of the investigator, makes the subject unsuitable for trial participation.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Chongqing, Chongqing Municipality, China
- Xiamen, Fujian, China
- Guangzhou, Guangdong, China
- Nanning, Guangxi, China
- Zhengzhou, Henan, China
- Changzhou, Jiangsu, China
- Jilin City, Jilin, China
- Chengdu, Sichuang, China
- Hangzhou, Zhejiang, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Chongqing, Chongqing Municipality, China; Xiamen, Fujian, China; Guangzhou, Guangdong, China; Nanning, Guangxi, China; Zhengzhou, Henan, China and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.