NCT02826018终止1 期
A Phase 1/2, Randomized, Single-Blind, Placebo-Controlled, Single-Ascending and Multiple-Ascending Dose, Safety, Tolerability, Pharmacokinetics, and Antiviral Efficacy Study of Subcutaneously Administered ALN-HBV in Healthy Adult Subjects and Non-cirrhotic Patients With Chronic Hepatitis B Virus (HBV) Infection
Alnylam Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2016年6月24日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Proportion of subjects experiencing adverse events
研究概览
简要总结
The purpose of this study is to determine the safety, tolerability and pharmacokinetics of ALN-HBV in healthy adult volunteers and patients with chronic hepatitis B virus (HBV) infection. In addition, the study will assess antiviral efficacy of ALN-HBV in patients with HBV.
详细描述
The study has 3 parts. Part A is a single ascending dose (SAD) study in healthy volunteers. Part B is a single ascending dose study (SAD) in patients with HBV infection. Part C is a multiple ascending dose study (MAD) in patients with HBV infection.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All subjects:
- •18 to 65 years inclusive
- •Women of child-bearing potential must have a negative pregnancy test, cannot be breast feeding, and must be willing to use a highly effective method of contraception
- •Agrees not to donate blood during the duration of the study
- •Willing to comply with the study requirements and to provide written informed consent
- •Additional inclusion criteria for patients with HBV infection:
- •Body mass index (BMI) ≥18.0 kg/m2
- •Must be on a stable regimen of entecavir or tenofovir
排除标准
- •All subjects:
- •Any uncontrolled or serious disease, or any medical or surgical condition, that may either interfere with participation in the clinical study, and/or put the subject at significant risk
- •Subjects with a history of serious mental illness
- •Active infection with human immunodeficiency virus (HIV) infection, hepatitis A virus (HAV), or hepatitis C virus (HCV) infection and/or a history of delta virus hepatitis
- •Known hypersensitivity or contraindication to any medication or history of allergic reaction to an oligonucleotide or N-acetylgalactosamine (GalNAc)
- •Additional exclusion criteria for healthy volunteers:
- •Evidence of liver disease
研究组 & 干预措施
ALN-HBV
Active Comparator
干预措施: ALN-HBV (Drug)
Sterile Normal Saline (0.9% NaCl)
Placebo Comparator
干预措施: Sterile Normal Saline (0.9% NaCl) (Drug)
结局指标
主要结局
Proportion of subjects experiencing adverse events
时间窗: Part A (SAD phase): through Day 29; Part B (SAD phase): through Day 85; Part C (MAD phase): through Day 176
次要结局
- Profile of Pharmacokinetics (PK) of ALN-HBV(Part A (SAD phase): Day 1; Part B (SAD phase): Day 1; Part C (MAD phase): Days 1 and 85)
- Change from baseline in quantitative hepatitis B surface antigen (HBsAg) levels(Part B (SAD phase): baseline through Day 85; Part C (MAD phase): baseline through Day 176)
研究者
研究点 (1)
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