A Phase 2a, Open-Label Multiple Dose Study Evaluating the Safety, Tolerability, and Pharmacodynamics of Imdusiran (AB-729) in Combination With Intermittent Dosing of Durvalumab, a PD-L1 Monoclonal Antibody, in Subjects With Chronic HBV Infection
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 21
- 主要终点
- To evaluate the safety and tolerability of imdusiran and durvalumab in NA suppressed CHB subjects
研究概览
简要总结
This is a phase 2a, open-label, multicenter study investigating the safety, tolerability, and antiviral activity of durvalumab administered at targeted times during a 48-week treatment period of imdusiran in virologically-suppressed CHB subjects
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
- 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
- •Male or female between the ages of 18-65
- •Willing and able to provide informed consent
- •Willing to follow protocol-specified contraception requirement
排除标准
- •Have extensive fibrosis or cirrhosis of the liver
- •Have or had liver cancer (hepatocellular carcinoma)
- •Family history or personal history/current thyroid disease on or off replacement therapy
- •Have a history or current autoimmune disease or has been on immunosuppressive medications within 6 months of the start of the study
- •Females who are breastfeeding, pregnant or who wish to become pregnant during the study
- •Known chronic or severe infection or recent significant exposure to infections such as tuberculosis or endemic mycosis, untreated latent infections like tuberculosis, or a positive or indeterminate QuantiFERON test.
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Cohort A
Imdusiran 60 mg SC Q8 weeks + nucleos(t)ide analog for 48 weeks + durvalumab at early and mid-treatment period timepoints
干预措施: Imdusiran (Drug)
Cohort A
Imdusiran 60 mg SC Q8 weeks + nucleos(t)ide analog for 48 weeks + durvalumab at early and mid-treatment period timepoints
干预措施: Durvalumab (Drug)
Cohort B
Imdusiran 60 mg SC Q8 weeks + nucleos(t)ide analog for 48 weeks + durvalumab at mid and late-treatment period timepoints
干预措施: Imdusiran (Drug)
Cohort B
Imdusiran 60 mg SC Q8 weeks + nucleos(t)ide analog for 48 weeks + durvalumab at mid and late-treatment period timepoints
干预措施: Durvalumab (Drug)
Cohort C
Imdusiran 60 mg SC Q8 weeks + nucleos(t)ide analog for 48 weeks + durvalumab at 2 late treatment period timepoints
干预措施: Imdusiran (Drug)
Cohort C
Imdusiran 60 mg SC Q8 weeks + nucleos(t)ide analog for 48 weeks + durvalumab at 2 late treatment period timepoints
干预措施: Durvalumab (Drug)
结局指标
主要结局
To evaluate the safety and tolerability of imdusiran and durvalumab in NA suppressed CHB subjects
时间窗: Up to 96 weeks
• Number of participants with treatment emergent adverse events (TEAEs), immune related adverse events (irAEs), with discontinuations due to adverse events (AEs) and irAEs, with abnormal laboratory tests results, abnormal Vital signs, abnormal physical exam findings and abnormal electrocardiogram (ECG) readings
次要结局
- To characterize the target engagement (TE) (pharmacodynamics [PD]) of durvalumab in CHB subjects over time(Up to 48 Weeks)
- To determine the proportion of subjects who meet NA treatment discontinuation criteria at Week 48(Up to Week 48)
- To determine the effect of imdusiran and durvalumab on HBsAg(Up to 96 Weeks)