A Phase 2, Randomized, Open-label, Ascending, Sequential Dose Group, Multiple Dose Study of the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of CMX157 in HBV-infected Subjects
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 主要终点
- Evaluation of the safety and tolerability of increasing multiple oral doses of CMX157 in HBV + patients
研究概览
简要总结
This is a phase 2a study to evaluate the safety and tolerability of multiple oral doses of CMX157 at increasing dose levels.
详细描述
This is a phase 2a study to evaluate the safety and tolerability of multiple oral doses of CMX157 at increasing dose levels in hepatitis B virus(HBV) infected subjects.
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
- None
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
- •Capable of giving written informed consent.
- •Capable of completing study requirements.
- •Chronic hepatitis B positive.
- •HBV treatment naïve.
排除标准
- •Positive result for HCV(hepatitis C virus), HDV(hepatitis D virus) or HIV(human immunodeficiency virus).
- •History or medical condition that could impact patient safety.
- •Current or past abuse of alcohol or illicit drugs.
- •Abnormal laboratory value or ECG.
- •Pregnant or breastfeeding.
- •Clinical, histologic or laboratory evidence of significant liver fibrosis or cirrhosis.
- •Systemic immunosuppression.
- •Received an investigational drug or investigational vaccine within the 90 days prior to the first dose of study drug.
研究组 & 干预措施
CMX157 100mg versus TDF
CMX157, 100mg tablet, 28 days versus TDF 300mg tablet, 28 days
干预措施: CMX157 (Drug)
CMX157 100mg versus TDF
CMX157, 100mg tablet, 28 days versus TDF 300mg tablet, 28 days
干预措施: TDF (Drug)
CMX157 5mg versus TDF
CMX157, 5mg tablet, 28 days versus TDF(tenofovir disoproxil fumerate) 300mg tablet, 28 days
干预措施: CMX157 (Drug)
CMX157 5mg versus TDF
CMX157, 5mg tablet, 28 days versus TDF(tenofovir disoproxil fumerate) 300mg tablet, 28 days
干预措施: TDF (Drug)
CMX157 10mg versus TDF
CMX157, 10mg tablet, 28 days versus TDF 300mg tablet, 28 days
干预措施: CMX157 (Drug)
CMX157 10mg versus TDF
CMX157, 10mg tablet, 28 days versus TDF 300mg tablet, 28 days
干预措施: TDF (Drug)
CMX157 25mg versus TDF
CMX157, 25mg tablet, 28 days versus TDF 300mg tablet, 28 days
干预措施: CMX157 (Drug)
CMX157 25mg versus TDF
CMX157, 25mg tablet, 28 days versus TDF 300mg tablet, 28 days
干预措施: TDF (Drug)
CMX157 50mg versus TDF
CMX157, 50mg tablet, 28 days versus TDF 300mg tablet, 28 days
干预措施: CMX157 (Drug)
CMX157 50mg versus TDF
CMX157, 50mg tablet, 28 days versus TDF 300mg tablet, 28 days
干预措施: TDF (Drug)
结局指标
主要结局
Evaluation of the safety and tolerability of increasing multiple oral doses of CMX157 in HBV + patients
时间窗: 28 days
Capture adverse events, physical examinations, ECGs and clinical laboratory panels
To evaluate the antiviral activity of CMX157 versus tenofovir disproxil fumarate(TDF).
时间窗: 28 days
HBV DNA levels
次要结局
- Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in HBV + subjects, Cmax.(28 days)
- Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in HBV + subjects: AUC.(28 days)
- Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in HBV + subjects: Tmax.(28 days)
- Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in HBV + subjects: Cmin.(28 days)