A Phase 1, Multi-center, Placebo-controlled, Dose-escalation Study of the Safety of IMO-2125 in Hepatitis C-infected Patients Unresponsive to Standard Treatment With Pegylated Interferon and Ribavirin
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 7
- 主要终点
- Evaluation of Safety.
研究概览
简要总结
First-in-humans, phase 1, dose-escalation study with 4 dose levels of single-agent IMO-2125.
详细描述
First-in-humans, phase 1, dose-escalation study with 4 dose levels of single-agent IMO-2125. Patients will proceed through a screening period, treatment period, and follow-up period of approximately 4 months' duration. There will be 4 dose cohorts including active drug and placebo dosing.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 否
入选标准
- •HCV-positive
- •Nonresponder to standard-dose pegylated interferon-α-2a or -α-2b in combination with standard-dose ribavirin
排除标准
- •Human immunodeficiency virus (HIV)or hepatitis B surface antigen (HbsAg)
- •Inadequate bone marrow, liver, and renal function
- •Treatment with any IFN (interferon)-based or other experimental or antiviral therapies within 30 days
- •Other significant medical diseases
- •Known alcohol or drug abuse within the past 12 months
研究组 & 干预措施
IMO-2125 0.04 mg/kg q week
IMO-2125 given weekly at 0.04 mg/kg
干预措施: IMO-2125 (Drug)
IMO-2125 0.08 mg/kg q week
IMO-2125 given weekly at 0.08 mg/kg
干预措施: IMO-2125 (Drug)
IMO-2125 0.16 mg/kg q week
IMO-2125 given weekly at 0.16 mg/kg
干预措施: IMO-2125 (Drug)
IMO-2125 0.32 mg/kg q week
IMO-2125 given weekly at 0.32 mg/kg
干预措施: IMO-2125 (Drug)
IMO-2125 0.48 mg/kg q week
IMO-2125 given weekly at 0.48 mg/kg
干预措施: IMO-2125 (Drug)
Placebo
Weekly saline placebo
干预措施: Saline placebo (Drug)
IMO-2125 0.16 mg/kg twice a week
IMO-2125 given twice a week at 0.16 mg/kg
干预措施: IMO-2125 (Drug)
结局指标
主要结局
Evaluation of Safety.
时间窗: From screening through study completion, 86 to 115 days in total
Count and percentage of subjects with treatment emergent adverse events
次要结局
未报告次要终点