NCT06680232招募中1 期
A Phase 1, Open-Label, First-in-Human, Dose Escalation (Part 1) and Expansion (Part 2) Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of PBGENE-HBV in Participants With Chronic Hepatitis B (ELIMINATE-B)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 10
- 主要终点
- Safety to Assess Treatment-emergent Adverse Events (TEAEs)
研究概览
简要总结
This is a Phase 1, open-label, dose escalation and dose expansion study to evaluate the safety, tolerability, PK, and antiviral activity of PBGENE-HBV in adult participants with chronic hepatitis B.
详细描述
Refer to key Inclusion and Exclusion criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or women of non-child bearing potential
- •BMI 18.0 to 35.0
- •Good overall health deemed by the study Investigator
- •CHB infection documented at least 12 months prior to screening
- •HBeAg-negative CHB
- •Must be virologically suppressed on current NA treatment
排除标准
- •No history of cirrhosis of the liver
- •No current infections of Hepatitis A, D, and E, human immunodeficiency virus (type 1 and 2), and no history of or current hepatitis C. In addition, no other active infections deemed clinically relevant.
- •No signs of hepatocellular carcinoma
- •Not received an organ transplant
- •No malignancy within 5 years of screening, except for specific cancers that are cured by surgical resection (e.g., basal cell skin cancer)
- •No investigational agent received within 6 months of screening
研究组 & 干预措施
Participants in both Part 1 and 2 will receive a finite course of PBGENE-HBV.
Experimental
All participants will receive a finite course of multiple IV dose administrations of PBGENE-HBV. In Part 1, this will be done in a dose escalation manner which may be evaluated further in a Part 2 expansion cohort.
干预措施: PBGENE-HBV (Biological)
结局指标
主要结局
Safety to Assess Treatment-emergent Adverse Events (TEAEs)
时间窗: 4 weeks after final dose
Frequency of TEAEs
次要结局
- Additional Safety(48 weeks)
- Pharmacokinetics of AUC(4 weeks)
- Pharmacokinetics of Cmax(4 weeks)
- Pharmacokinetics of Cmin(4 weeks)
- Pharmacokinetics of half life (t1/2)(4 weeks)
- Antiviral Activity of HBsAg and Anti-HBs(48 weeks)
- Antiviral Activity of HBV DNA(48 weeks)
研究者
研究点 (10)
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