Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: 2025 Eurostat Trade Data and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: 2025 Eurostat Trade Data and Economic Impact
Active, not recruiting Phase 2

A Study to Evaluate the Antiviral Activity and Immune Response of AHB-137 Injection in Participants With Chronic Hepatitis B (CHB)

NCT06993480 · tracked via the Priya Life Science China tracker
Phase
Phase 2
Started
2025-07-15
Last updated
2026-08-10

Condition(s) studied

Chronic Hepatitis B

Investigational drug(s) / intervention(s)

AHB-137 →

AHB-137: AHB-137 300 mg will be injected subcutaneously once a week (total 24 weeks).

Study summary

This study is a single-center, open-label Phase II clinical study to evaluate the antiviral activity and immune responses of AHB-137 injection in participants with CHB treated with nucleos (t) ide analogues.

Eligibility

Sex
ALL
Min age
18 Years
Max age
55 Years
Healthy volunteers
No
Inclusion Criteria: * Voluntarily participated in the study and signed an informed consent form; * Aged between 18 and 55 years at the time of signing the informed consent form; * Body mass index (BMI) within the range of 18-30 kg/ m2; * HBeAg negative or positive at screening; * HBsAg or HBV DNA positive for at least 6 months; * Have been on continuous nucleos(t)ide analogues antiviral therapy for more than 6 months prior to screening; * 100 IU/mL \< HBsAg ≤ 3000 IU/mL and HBV DNA \< 100 IU/mL at screening; * Alanine aminotransferase (ALT) ≤ 2 × upper limit of normal (ULN); * Effective contraception as required. Exclusion Criteria: * Clinically significant abnormalities other than a history of CHB infection; * Concomitant clinically significant other liver diseases; * Any serious infection other than CHB infection requiring intravenous anti-infective therapy within 1 month prior to screening; * Active hepatitis C, Human immunodeficiency virus (HIV) positive, syphilis positive; * Liver stiffness value (LSM) \> 9.0 kPa at screening; * Diagnosis or suspicion of hepatocellular carcinoma, or alpha-fetoprotein (AFP) concentration ≥ 20 ng/mL at screening; * Participants with confirmed or suspected hepatic decompensated hepatitis B cirrhosis; * Liver biopsy at screening assessed severity of activity ≥ G3 grade and/or fibrosis reaching S4 stage; * History of extrahepatic disease possibly related to HBV immune status; * Ongoing or taking any immunosuppressive medication within 3 months prior to screening. Those who have used immunomodulators and cytotoxic drugs within 6 months prior to the first dose, or have a history of vaccination within 1 month prior to screening or have a live vaccination plan during the trial; Continuous use of traditional Chinese medicine for more than 2 months within 1 year prior to screening, or within 1 month prior to screening; Ongoing use of anticoagulants, bleeding tendency or coagulopathy, or conditions that, in the opinion of the investigator, increase the risk of liver biopsy; * Receiving or using any interferon-containing therapy within 12 months prior to screening; * History of malignancy within 5 years prior to screening or being evaluated for possible malignancy; * Suspected history of allergy to any component of the study drug, or allergic constitution (multiple drug and food allergy, and judged by the investigator to be clinically significant); * Major trauma or major surgery within 3 months prior to screening, or planned surgery during the study; * Donation or blood loss ≥ 400 mL, or received blood transfusion within 12 weeks prior to screening; Or blood donation or blood loss ≥ 200 mL within 1 month prior to screening; * Participants who are participating in another clinical trial, or have not undergone a protocol-specified washout period prior to this study; * Received any antisense oligonucleotides (ASO) or using any small molecule interfering ribonucleic acid (siRNA) drug within 12 months prior to screening; * Participants with abnormal thyroid function judged by the investigator to be ineligible for enrollment; * Obviously abnormal laboratory test results; * History of vasculitis or signs and symptoms of underlying vasculitis; * Any other circumstance or condition that, in the opinion of the investigator, the participants are inappropriate for participation in the study.

Primary outcome measure(s)

  • Proportion of participants with serum HBsAg < limit of detection (LOD) 0.05 international unit per milliliter (IU/mL) and Hepatitis B Virus (HBV) DNA < lower limit of quantification (LLOQ) with or without HBsAb seroconversion. — Up to 24 weeks

Trial sites (1)

FacilityCityRegionStatus
The Second Affiliated Hospital of Chongqing Medical University Chongqing Chongqing Municipality
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06993480 on ClinicalTrials.gov ↗ ← All trials in China