A Double-Blind, Randomized, Placebo-Controlled, Single and Multiple Dose Study Evaluating the Safety, Tolerability, PK and PD of AB-101, an Oral PD-L1 Inhibitor, in Healthy Subjects and Subjects With Chronic HBV Infection.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 11
- 主要终点
- Parts 1 and 2: Incidence of adverse events (AEs), serious AEs (SAEs), immune related AEs (irAEs) and discontinuations due to AEs and irAEs.
研究概览
简要总结
This three-part, Phase 1 protocol will be the first clinical study of AB-101. Parts 1 and 2 will be a Phase 1a SAD/MAD of AB-101 in healthy adult subjects.
Part 3 will be a Phase 1b dose-ranging assessment of AB-101 in non-cirrhotic Chronic Hepatitis B (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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Part 1 and 2 (Healthy Volunteers)
- •Male between ages 18-50 years
- •Willing and able to provide informed consent
- •Willing to follow protocol-specified contraception requirement
- •Inclusion Criteria: Part 3 (CHB Subjects)
- •Male or female subjects between the ages of 18-60 years
- •Willing to provide informed consent
- •Chronic HBV infection for at least 6 months
- •Willing to follow protocol-specified contraception requirement
排除标准
- •Part 1 and 2 (Healthy Volunteers)
- •Key Exclusion Criteria:
- •Clinically significant lab abnormalities
- •A history of clinically significant gastrointestinal, hematologic, renal, hepatic, bronchopulmonary, neurological, psychiatric, cardiovascular, autoimmune or other immune-mediated disease.
- •HIV or Hep C positive
- •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.
- •Exclusion Criteria: Part 3 (CHB Subjects)
- •Have extensive fibrosis or cirrhosis of the liver
- •Have or had liver cancer (hepatocellular carcinoma)
- •Have a history or current autoimmune disease or has been on immunosuppressive medications within 6 months of the start of the study
- •Females who 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.
研究组 & 干预措施
Part 1
干预措施: Placebo (Drug)
Part 2
干预措施: Placebo (Drug)
Part 3
干预措施: Nucleos(t)ide Analogue (Drug)
Part 3
干预措施: Placebo (Drug)
Part 3
干预措施: AB-101 (Drug)
Part 2
干预措施: AB-101 (Drug)
Part 1
干预措施: AB-101 (Drug)
结局指标
主要结局
Parts 1 and 2: Incidence of adverse events (AEs), serious AEs (SAEs), immune related AEs (irAEs) and discontinuations due to AEs and irAEs.
时间窗: [Time Frame: Up to 57 (Part 1) or 84 (Part 2) days]
Part 3: Incidence of AEs, SAEs, irAEs and discontinuations due to AEs and irAEs
时间窗: [Time Frame: Up to 196 days]
Parts 1 and 2: Incidence of clinically significant laboratory abnormalities Parts 1 and 2: Incidence of clinically significant laboratory abnormalities
时间窗: [Time Frame: Up to 57 (Part 1) or 84 (Part 2) days]
Parts 1 and 2: Incidence of clinically significant changes in vital signs (heart rate, blood pressure, temperature, respiratory rate), physical examinations and electrocardiograms (ECGs)
时间窗: [Time Frame: Up to 57 (Part 1) or 84 (Part 2) days]
Part 3: Incidence of clinically significant laboratory abnormalities
时间窗: [Time Frame: Up to 196 days]
Part 3: Incidence of clinically significant changes in vital signs (heart rate, blood pressure, temperature, respiratory rate), physical examinations and electrocardiograms (ECGs)
时间窗: [Time Frame: Up to 196 days]
次要结局
未报告次要终点
研究者
Tilly Varughese
Scientific
Arbutus Biopharma Inc.