A Phase 1a/1b Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of EDP 514 in Healthy Subjects (Part 1), and Antiviral Activity in Nucleos(t)Ide Reverse Transcriptase Inhibitor (NUC)-Suppressed Patients With Chronic Hepatitis B Virus Infection (Part 2)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 15
- 主要终点
- Safety measured by adverse events
研究概览
简要总结
Part 1 is a randomized, double-blind, placebo-controlled study. It will assess the safety, tolerability, and pharmacokinetics of single and multiple orally administered doses of EDP-514 in healthy adult subjects.
Part 2 is randomized, double -blind, placebo-controlled study including subjects with Hepatitis B Virus. It will assess the safety, tolerability, pharmacokinetics and antiviral activity of 28 Days of orally administered doses of EDP-514 in nucleos(t)ide reverse transcriptase inhibitor (NUC)-Suppressed Patients with Chronic Hepatitis B Virus Infection
详细描述
Part 1 consists of two phases planned in healthy subjects:
The first phase assesses single ascending doses for EDP-514 (active drug or placebo) in healthy subjects. A "fasted" and "fed" two-part cohort will also assess food effect.
The second phase assesses multiple ascending doses (active drug or placebo) for 14 days in healthy subjects.
Each cohort within each phase will enroll a total of 8 subjects who will be randomized to receive EDP-514 or placebo. The cohort assessing food effect will enroll 10 subjects randomized to receive EDP-514 or placebo.
Part 2 assesses multiple ascending doses EDP-514 (active drug or placebo) for 28 days in nucleos(t)ide reverse transcriptase inhibitor (NUC)-Suppressed Patients with Chronic Hepatitis B Virus Infection.
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
- Quadruple (Participant, Care Provider, 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
- 是
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 65 years, inclusive.
排除标准
- •Clinically relevant evidence or history of illness or disease.
- •Pregnant or nursing females.
- •History of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection.
- •A positive urine drug screen at screening or Day -
- •Current tobacco smokers or use of tobacco within 3 months prior to screening.
- •Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy).
- •History of regular alcohol consumption.
- •Receipt of any vaccine, an investigational agent or biological product within 28 days or 5 times the t½, whichever one is longer, prior to first dose. This includes agents administered during clinical trial participation.
- •Part 2 (HBV Population):
- •Inclusion Criteria:
- •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:
- •A Screening HBV DNA level in serum/plasma that is <LLOQ and
- •No HBV DNA serum/plasma test values ≥LLOQ over the previous 12 months (using an approved test)
- •CHB subjects must have been on their prescribed HBV NUC treatment with no change in regimen for 12 months prior to Screening
- •Exclusion Criteria:
- •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 HV SAD Cohorts
EDP-514 Dose 1, Dose 2, Dose 3, Dose 4, Dose 5 and Dose 6 orally, once daily in one single administration
干预措施: EDP-514 (Drug)
EDP-514 HV MAD Cohorts
EDP-514 Dose 1, Dose 2 and Dose 3 orally, once daily for 14 days
干预措施: EDP-514 (Drug)
EDP-514 HV SAD Placebo Cohort
Matching placebo, orally, once daily in one single administration
干预措施: Placebo (Drug)
EDP-514 HV MAD Placebo Cohort
Matching placebo, orally, once daily for 14 days
干预措施: Placebo (Drug)
EDP-514 HBV MAD Cohorts
EDP-514 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
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 56 Days in HBV MAD Cohorts
次要结局
- Cmax of EDP-514(Up to 28 Days in HBV MAD Cohorts)
- AUC of EDP-514(Up to 28 Days in HBV MAD Cohorts)