NCT07630727招募中2 期
An Open-label Phase II Clinical Study to Evaluate the Efficacy and Safety of AHB-171 Injection in Participants With Chronic Hepatitis B
Ausper Biopharma Co., Ltd.10 个研究点 分布在 1 个国家目标入组 138 人开始时间: 2026年6月24日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 138
- 试验地点
- 10
研究概览
简要总结
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 prior antiviral treatment duration requirements.
- •Adopt effective contraceptive measures as required
排除标准
- •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 trauma or major surgery within 12 weeks prior to screening
- •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.
研究组 & 干预措施
AHB-171 in Treatment CHB
Experimental
干预措施: AHB-171 Injection (Drug)
AHB-171 in Naïve CHB
Experimental
干预措施: AHB-171 Injection (Drug)
结局指标
主要结局
未指定
次要结局
- Change of HBsAg (log₁₀ IU/mL) from baseline and maximum reduction at each visit(Up to 90 days)
研究者
研究点 (10)
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