A Double-Blind, Randomized, Placebo-Controlled, Single and Multiple-Dose Ranging Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antiviral Activity of GS-9620 in Treatment Naive Subjects With Chronic Hepatitis C Virus Infection
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 10
- 主要终点
- Incidence of adverse events in single and multiple doses of GS-9620
研究概览
简要总结
Dose cohorts may be dosed with one of up to 4 possible total weekly doses (0.3 mg, 1 mg, 2 mg, 4 mg). Dose escalation or repetition will be governed by pre-specified safety and activity rules. Subjects will be confined on either days 1-3 and/or days 8-10. Follow-up visits are also required periodically through day 43. Study procedures involve taking blood samples for pharmacokinetic, pharmacodynamic, virologic, and safety assessments.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Males and Females 18-65 years old
- •Chronic HCV infection for at least 6 months, treatment naive
- •HCV Viral load > 100,000 IU/mL at Screening
- •Monoinfection with HCV 1 genotype
- •Hepatitis B surface antigen negative
- •Screening ECG without clinically significant abnormalities
- •BMI 18-33 kg/m^2
- •Creatinine clearing > 70 mL/min
- •Negative pregnancy test at screening
排除标准
- •Pregnant or lactating subjects
- •Co-infection with hepatitis B virus (HBV) or HIV
- •History of Gilberts disease
- •Particular abnormal laboratory parameters
- •Diagnosis of autoimmune disease, poorly controlled diabetes, significant psychiatric illness, severe chronic obstructive pulmonary disease (COPD), malignancy, hemoglobinopathy, retinal disease, and those who are immunosuppressed
- •Evidence of hepatocellular carcinoma
- •On-going alcohol abuse
- •Positive uring drug screen
研究组 & 干预措施
0.3mg GS-9620
干预措施: Single Ascending Dose Cohorts GS-9620 (Drug)
1mg GS-9620
干预措施: Single Ascending Dose Cohorts GS-9620 (Drug)
2mg GS-9620
干预措施: Single Ascending Dose Cohorts GS-9620 (Drug)
4mg GS-9620
干预措施: Single Ascending Dose Cohorts GS-9620 (Drug)
0.3mg GS-9620 QW x 2 doses
干预措施: Multiple Ascending Dose Cohorts GS-9620 (Drug)
1mg GS-9620 QW x 2 doses
干预措施: Multiple Ascending Dose Cohorts GS-9620 (Drug)
2mg GS-9620 QW x 2 doses
干预措施: Multiple Ascending Dose Cohorts GS-9620 (Drug)
4mg GS-9620 QW x 2 doses
干预措施: Multiple Ascending Dose Cohorts GS-9620 (Drug)
结局指标
主要结局
Incidence of adverse events in single and multiple doses of GS-9620
时间窗: Periodically Day 1 to 6 months
Assessments include adverse events, laboratory abnormalities, 12-lead ECG abnormalities and interval measurements, and vital sign measurements
次要结局
- Assessment of plasma drug concentrations of GS-9620 using non-compartmental methods(Day 1 and Day 8)
- Measurement of pharmacodynamic markers (cytokines and interferon-stimulated genes [ISGs])(Days 1, 2, 3, 5, 8)
- Reduction of hepatitis C (HCV) RNA viral load from baseline(Screening, Baseline, Day 8 or 15)