NCT04470388已完成1 期
A Phase 1b Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of EDP 514 in Viremic Chronic Hepatitis B Virus Infected Patients Not Currently on Treatment
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
- 25
- 试验地点
- 10
- 主要终点
- Safety measured by adverse events
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled study in viremic chronic hepatitis B subjects, assessing the safety, tolerability, pharmacokinetics and antiviral activity of 28 Days treatment with EDP-514.
详细描述
The study assesses multiple ascending doses of EDP-514 compared to placebo for 28 days in viremic chronic CHB-infected subjects not currently on treatment.
Each cohort will enroll a total of 8 subjects who will be randomized to receive EDP-514 or placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •An informed consent document signed and dated by the subject.
- •Healthy male and female subjects of any ethnic origin between the ages of 18 and 70 years, inclusive
- •HBV DNA levels:
- •For subjects who are HBeAg positive at Screening, a Screening HBV DNA level in serum/plasma that is ≥20,000 IU/ml, or
- •For subjects who are HBeAg negative at Screening, a Screening HBV DNA level in serum/plasma that is ≥2,000 IU/mL, and
- •For all subjects, no HBV DNA serum/plasma test values <1,000 IU/ml over the previous 12 months (using an approved test)
- •CHB subjects must not have been on prescribed anti-HBV treatment for at least 12 months prior to Screening
排除标准
- •A documented prior diagnosis of cirrhosis
- •Pregnant or nursing females
- •Coinfection with human immunodeficiency virus (HIV), HCV, HDV, HAV, or HEV
- •Chronic liver disease of a non-HBV etiology; coexisting liver or biliary diseases
研究组 & 干预措施
EDP-514 HBV MAD Cohorts
Experimental
EDP-514 capsule Dose 1, Dose 2 and Dose 3 orally, once daily for 28 days.
干预措施: EDP-514 (Drug)
EDP-514 HBV MAD Placebo Cohort
Placebo Comparator
Matching placebo, orally, once daily for 28 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Safety measured by adverse events
时间窗: Up to 84 Days in HBV MAD Cohorts
次要结局
- AUC of EDP-514(Up to 28 Days in HBV MAD Cohorts)
- Cmax of EDP-514(Up to 28 Days in HBV MAD Cohorts)
- Change from baseline in HBV DNA Viral Load Assay(through Day 28 in HBV MAD Cohorts)
研究者
研究点 (10)
Loading locations...
相似试验
已完成
1 期
Study of VIR-2218 in Healthy Subjects and Patients With Chronic Hepatitis BChronic Hepatitis BNCT03672188Vir Biotechnology, Inc.82
已完成
2 期
A Study of Hepalatide Combined With TAF and PEG-IFN as Finite Treatment of Chronic Hepatitis B PatientsChronic Hepatitis BNCT05244057Shanghai HEP Pharmaceutical Co., Ltd.8
已完成
1 期
Study of VIR-3434 in Healthy Volunteers and Patients With Chronic Hepatitis B Virus InfectionChronic Hepatitis BNCT04423393Vir Biotechnology, Inc.113
已完成
1 期
Effects of CSL324 in the Lung After Segmental ChallengeHealthy VolunteersNCT05653713CSL Behring40
已完成
1 期
Study to Assess the Safety, Pharmacokinetics/Dynamics of DS-1040b in Subjects With Acute Submassive Pulmonary EmbolismThrombotic DiseasePulmonary EmbolismNCT02923115Daiichi Sankyo134