ACTRN12619001210167已完成1 期
A Phase Ib/IIa Randomized, Controlled Dose Escalation Study to EvaluateSafety, Tolerability, and Antiviral Activity of BRII-179 (VBI-2601) amongSubjects with Chronic Hepatitis B
Brii Biosciences0 个研究点目标入组 49 人开始时间: 2019年8月30日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 49
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 60 Years（—）
- 性别
- All
入选标准
- •1) Male or female age 18 to 60
- •2) BMI 18 to 32 kg per meter 2
- •3) Chronic HBV infection for greater than or equal 6 months
排除标准
- •1) Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation
- •2) Significant fibrosis or cirrhosis
- •3) History or evidence of drug or alcohol abuse
- •4) History of intolerance to intramuscular injection
- •5) History of chronic liver disease from any cause other than chronic HBV infection
- •6) History of hepatic decompensation
研究者
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