NCT06829329进行中（未招募）2 期
A Randomized, Multi-center Phase II Study to Evaluate the Efficacy and Safety of AHB-137 in Treatment-naive Participants With CHB
Ausper Biopharma Co., Ltd.10 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2024年12月13日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 105
- 试验地点
- 10
- 主要终点
- Proportion of participants achieving HBsAg lower than limit of detection (LOD) (0.05 IU/mL) and HBV DNA lower than lower limit of quantitation (LLOQ).
研究概览
简要总结
The study is to evaluate the efficacy and safety of AHB-137 in CHB participants. The total duration of the study, including screening phase, treatment phase and follow-up phase.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Participants voluntarily participate in the study, and sign the Informed Consent Form (ICF) prior to screening, able to complete the study according to the protocol;
- •Male or female participants aged 18-65 years old (including the boundary value) at the time of signing the ICF;
- •Male participants weighed higher than 50 kg and female participants weighted higher than 50 kg, Body Mass Index (BMI) between 18 to 32 kg/m^2(inclusive);
- •Participants with positive HBsAg or HBV DNA greater than or equal to (≥) 6 months prior to screening and has not received antiviral treatment with interferon or NAs ;
- •At screening, ALT<3×upper limit of normal (ULN);
- •Use effective contraception as required;
- •HBV DNA within the specified range at screening;
- •HBsAg was within the specified range at screening.
排除标准
- •Clinically significant abnormalities except chronic HBV infection;
- •Any clinically significant liver diseases;
- •Participants with severe infection requiring systemic anti-infection treatment 1 month before enrollment;
- •Active hepatitis C, HIV antibody positive, treponema pallidum antibody positive;
- •Hepatobiliary neoplasm malignant;
- •The laboratory examination results are obviously abnormal;
- •History of vasculitis or signs and symptoms of potential vasculitis;
- •Anti-neutrophil cytoplasmic antibodies (ANCA) was positive at screening.
- •History of extrahepatic disease that may be related to HBV immune status;
- •Administration of immunosuppressants within 3 months prior to screening, except for short-term use (≤2 weeks) or topical/inhaled steroids. Administration of immunomodulators (thymosin) and cytotoxic drugs within 6 months prior to the first study intervention or have a history of vaccination within 1 month prior to screening or planned administration during the study;
- •History of malignancy within the past 5 years or the discovery of suspected tumors during the screening period;
- •Any suspicion of drug component allergy, or allergic constitution (various drug and food allergy, and judged by the investigator to be clinically significant) in participants;
- •Participants who have significant trauma or major surgery within 3 months before screening, or plan to perform surgery during the study;
- •Blood donation or blood loss more than 400 mL within 12 weeks before screening; Blood transfusion; Blood donation or blood loss not less than 200 mL within 1 month before screening;
- •Those who are participating in another clinical trial, or have not undergone a protocol-specified washout period prior to this study;
- •Participants who have received any oligonucleotide or small molecule interfering ribonucleic acid (siRNA) drugs;
- •Any other circumstances or conditions for which the investigator considers that the participants are inappropriate to participate in the study.
研究组 & 干预措施
AHB-137 and Nucleos(t)Ide Analogue (NAs)
Experimental
干预措施: AHB-137 (Drug)
AHB-137 and placebo
Experimental
干预措施: AHB-137 (Drug)
AHB-137 and placebo
Experimental
干预措施: Placebo (Drug)
AHB-137 and Nucleos(t)Ide Analogue (NAs)
Experimental
干预措施: NAs (Drug)
结局指标
主要结局
Proportion of participants achieving HBsAg lower than limit of detection (LOD) (0.05 IU/mL) and HBV DNA lower than lower limit of quantitation (LLOQ).
时间窗: Up to 24 weeks
次要结局
- Proportion of participants achieving functional cure during 24 weeks after discontinuation of all CHB therapy.(Up to 48 weeks)
- Number of Participants With HBsAg<LOD (0.05 IU/mL) and the percentage of participants with different levels of HBsAg reduction compared with baseline.(Up to 48 weeks)
- Number of participants with HBV DNA<LLOQ and the percentage of participants with different HBV DNA reduction.(Up to 48 weeks)
- Proportion of participants achieving HBsAg<LOD and HBV DNA<LLOQ, with or without HBsAb(Up to 48 weeks)
- Serum levels of HBsAg, HBV DNA, HBV RNA, HBcrAg, HBsAb(Up to 48weeks)
- Changes of the score of hepatitis B quality of life instrument (HBQOL) compared with baseline(Up to 48 weeks)
- Percentage of participants who reached HBeAg negative(Up to 48 weeks)
- Percentage of participants achieving HBeAg seroconversion(Up to 48 weeks)
- Time of ALT normalization in absence of rescue therapy(Up to 48 weeks)
- Proportion of participants with ALT normailzation in absence of rescue therapy.(Up to 48 weeks)
- The pharmacokinetic profile of AHB-137: Maximum concentration (Cmax) of AHB-137 in plasma(Up to 48 weeks)
- Safety: number of participants with treatment-emergent adverse events (TEAEs), treatment-related adverse events(TRAEs), serious adverse events (SAE) and clinically significant examination results(Up to 48 weeks)
- Immunogenicity: number and percentage of participants with detectable anti-drug antibodies (ADA)(Up to 48 weeks)
- The pharmacokinetic profile of AHB-137: Area under the concentration-time curve (AUC) of AHB-137(Up to 48 weeks)
- Plasma concentrations of AHB-137(Up to 48 weeks)
研究者
研究点 (10)
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