Phase 1b Multicenter, Open-Label Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Tune-401 in Participants With Chronic Hepatitis B Infection
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 6
- 主要终点
- Safety as assessed by treatment emergent adverse events
研究概览
简要总结
This study will be conducted to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of Tune-401 in adult participants with Chronic Hepatitis B.
详细描述
This study consists of an open-label, Part I single-ascending dose phase and Part II single and finite multiple dose phase to characterize the activity of Tune-401 on PD parameters and obtain safety data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •M/F, BMI ≥ 18.5 kg/m² at screening, age 18-75, inclusive
- •Diagnosed with Chronic Hepatitis B
- •On nucleos(t)ide analogue
- •HBeAg-negative or positive
排除标准
- •ALT/ AST ≥ 1.5 × upper limit of normal (ULN) and total bilirubin ≥
- •Participants with any evidence or history of liver disease of non-HBV etiology
- •Other protocol defined Inclusion/Exclusion criteria may apply
研究组 & 干预措施
Tune-401 Part II :Single/Finite Multiple Dose
Epigenetic gene silencing system delivered by lipid nanoparticles (LNPs) for intravenous (IV) administration
干预措施: Tune-401 (Genetic)
Tune-401 Part I : Single Ascending Dose
Epigenetic gene silencing system delivered by lipid nanoparticles (LNPs) for intravenous (IV) administration
干预措施: Tune-401 (Genetic)
结局指标
主要结局
Safety as assessed by treatment emergent adverse events
时间窗: 20 weeks
Number of participants with treatment-related adverse events (TEAEs)
次要结局
- Tune-401 Pharmacokinetics (half-life)(8 weeks)
- Long-term safety(104 weeks)
- Tune-401 Pharmacokinetics (Cmax)(8 weeks)
- Tune-401 Pharmacokinetics (Tmax)(8 weeks)
- Tune-401 Pharmacokinetics (AUC)(8 weeks)
- Tune-401 Pharmacokinetics (CL)(8 weeks)
- Tune-401 Pharmacokinetics (Vd)(8 weeks)
- Tune-401 Pharmacodynamics(104 weeks)
- Tune-401 Immunogenicity(104 weeks)