NCT00823862已完成1 期
A Phase I, Randomized, Single-Blind, Placebo-Controlled Dose-Escalation Study of SD-101 to Assess the Safety, Pharmacodynamics, and Preliminary Evidence of Anti-Viral Effect in Subjects Diagnosed With Chronic Hepatitis C, Genotype 1
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 5
- 主要终点
- Adverse event timing, duration, and severity.
研究概览
简要总结
To determine safety, tolerability, and preliminary efficacy of escalating doses of SD-101 alone and SD-101 plus ribavirin in subjects with chronic hepatitis C and no prior therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed, written, informed consent
- •Male or female subjects, 18 to 55 years of age.
- •Subject must have chronic infection HCV, genotype
- •Serum HCV-RNA concentrations 100,000 IU/mL to 10,000,000 IU/mL
- •No prior treatment for HCV.
- •Must be negative for hepatitis B (HBV) and human immunodeficiency virus (HIV).
- •Must be willing to use dual method of contraception (i.e., barrier and spermicide; birth control pills and barrier) during the study.
- •No known hypersensitivity to study medication or to drugs chemically related to the study.
排除标准
- •Prior treatment with IFN-based therapies and/or anti-viral therapies.
- •Women with ongoing pregnancy or breast feeding and male partners of women who are pregnant.
- •Reduced kidney function.
- •Presence of concomitant liver diseases
- •Signs or symptoms of hepatocellular carcinoma.
- •Thyroid disease currently poorly controlled on prescribed medications.
- •History of hemoglobinopathy.
- •Evidence of severe retinopathy.
- •Other serious medical conditions, including human immunodeficiency virus, cancer (excluding non-melanoma skin cancer), or evidence of drug or alcohol abuse.
- •Subjects with documented or presumed coronary artery disease, pulmonary disease, or cerebrovascular disease
- •Clinically significant acute or chronic illnesses.
- •History of severe psychiatric disease, especially depression, characterized by a suicide attempt, hospitalization for psychiatric disease, or a period of disability as a result of psychiatric disease.
研究组 & 干预措施
Active (SD-101)
Experimental
SD-101 in cohorts of escalating doses
干预措施: ribavirin (Drug)
Active (SD-101)
Experimental
SD-101 in cohorts of escalating doses
干预措施: SD-101 (Drug)
结局指标
主要结局
Adverse event timing, duration, and severity.
时间窗: Between doses and up to 3 months after last dose
次要结局
- Viral load in blood sample(each visit)
- Biomarker analysis of blood sample(pre and 24 hour post dose)
研究者
研究点 (5)
Loading locations...
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