NCT07617194尚未招募1 期
A Phase 1 Study in Chronic Hepatitis B Participants to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AHB-171
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 144
- 试验地点
- 2
研究概览
简要总结
The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of AHB-171 in participants with chronic hepatitis B (CHB). Study advancement to subsequent parts/cohorts will require satisfactory interim reviews of available cumulative safety data by the Safety Review Committees (SRC), using the safety criteria and review procedures described in the protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Male or female participants, aged 18-65 years old (inclusive)
- •Body Mass Index between 19 to 35 kg/m2 (inclusive)
- •Body weight > or = 45 kg.
- •Documented HBV infection for ≥6 months prior to randomization.
- •For Parts A and B, on stable approved NA monotherapy for at least 6 months prior to randomization.
- •For Part C and D only, not on any NA monotherapy for at least 6 months prior to randomization.
- •Screening electrocardiogram (ECG) without clinically significant abnormalities
- •Females of childbearing potential must not be breastfeeding, must have a negative serum pregnancy test at Screening, and a negative urine/serum pregnancy test before dosing (unless permanently sterile or >2 years postmenopausal).
- •Males and females of childbearing potential must agree to use protocol specified reliable contraception throughout the study.
- •Screening HBV DNA, HBsAg and ALT must meet prespecified requirements.
排除标准
- •Significant medical conditions other than chronic HBV (e.g. recent heart issues, unstable cardiac disease, uncontrolled diabetes, bleeding disorders, prior organ transplant).
- •Other clinically significant liver diseases (e.g. hepatitis from other causes, autoimmune or alcoholic liver disease, prior liver failure).
- •History of suspected or confirmed cirrhosis (based on FibroScan® or biopsy).
- •Current, past, or suspected liver cancer, or elevated alpha-fetoprotein (AFP) ≥ 20 ng/mL.
- •HBV-related extrahepatic diseases (e.g. kidney or vascular conditions).
- •Severe infection (other than chronic HBV infection) within 1 month before randomization requiring intravenous treatment.
- •Active infections: human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis D virus (HDV) or syphilis (exceptions if RNA negative).
- •Abnormal lab results (e.g. low albumin, reduced kidney function, abnormal INR, low platelets, high bilirubin, abnormal blood counts, significant proteinuria).
- •History or signs of vasculitis or related autoimmune diseases.
- •Malignancy within 5 years (except non-melanoma skin cancer).
- •Allergy to study drug components.
- •Recent major surgery/trauma (within 3 months) or planned surgery during study.
- •Alcohol or substance abuse affecting compliance.
- •Pregnancy, breastfeeding, or unwillingness to follow reproductive restrictions.
- •Participation in another clinical trial or recent investigational product use.
- •Prior treatment with any antisense oligonucleotide or small interfering RNA therapies.
- •Recent or ongoing use of immunosuppressive/biologic therapies, certain vaccines, bulevirtide, or unapproved herbal remedies.
- •Need for long-term anticoagulants/antiplatelet drugs (unless safely stopped).
- •Any other condition making the participant unsuitable (per investigator).
研究者
研究点 (2)
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