A Study of EDP-514 in Healthy Subjects (Part 1) and Patients With Chronic Hepatitis B Virus Infection (Part 2)
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)
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
研究概览
详细说明
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.
Each cohort in Part 2 will enroll a total of 8 subjects who will be randomized to receive EDP-514 or placebo.
研究类型
注册 (实际的)
阶段
- 阶段1
联系人和位置
学习地点
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Alberta
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Calgary、Alberta、加拿大、T2N 4Z6
- University of Calgary
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British Columbia
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Vancouver、British Columbia、加拿大、V6Z 2K5
- Gastroenterology Institute of Research Institute
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Ontario
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Toronto、Ontario、加拿大、M5G 2C4
- Toronto General Hospital
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Quebec
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Montréal、Quebec、加拿大、H2X 0A9
- Centre Hospitalier de l'Universite de Montreal
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California
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Coronado、California、美国、92118
- Southern California GI and Liver Centers
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Los Angeles、California、美国、90095
- University of California Los Angeles
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San Diego、California、美国、92105
- Tuan Nguyen Md Gastroenterology & Hepatology (Tuan Nguyen, M.D., Inc.)
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San Francisco、California、美国、94115
- Quest Clinical Research
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Florida
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Miami、Florida、美国、33136
- University of Miami Miller School of Medicine
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Kansas
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Lenexa、Kansas、美国、66219
- Pharmaceutical Research Associates, Inc.
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Maryland
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Catonsville、Maryland、美国、21228
- Digestive Disease Associates - Catonsville
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New York
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New York、New York、美国、10029
- Icahn School of Medicine at Mount Sinai
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Texas
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Houston、Texas、美国、77030
- American Research Corporation
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San Antonio、Texas、美国、78215
- The Texas Liver Institute
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Washington
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Seattle、Washington、美国、98104
- Swedish Organ Transplant and Liver Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Part 1 (HV 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 65 years, inclusive.
Exclusion Criteria:
- 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 -1.
- 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
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:顺序分配
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的: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
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Oral Capsule; Subjects will receive either a single dose of EDP-514 on Day 1 only (SAD HV), once daily dosing of EDP-514 starting on Day 1 through Day 14 (MAD HV) or once daily dosing of EDP-514 starting on Day 1 through Day 28 (MAD HBV).
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实验性的:EDP-514 HV MAD Cohorts
EDP-514 Dose 1, Dose 2 and Dose 3 orally, once daily for 14 days
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Oral Capsule; Subjects will receive either a single dose of EDP-514 on Day 1 only (SAD HV), once daily dosing of EDP-514 starting on Day 1 through Day 14 (MAD HV) or once daily dosing of EDP-514 starting on Day 1 through Day 28 (MAD HBV).
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安慰剂比较:EDP-514 HV SAD Placebo Cohort
Matching placebo, orally, once daily in one single administration
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与 EDP-514 匹配的安慰剂
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安慰剂比较:EDP-514 HV MAD Placebo Cohort
Matching placebo, orally, once daily for 14 days
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与 EDP-514 匹配的安慰剂
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实验性的:EDP-514 HBV MAD Cohorts
EDP-514 Dose 1, Dose 2 and Dose 3 orally, once daily for 28 days
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Oral Capsule; Subjects will receive either a single dose of EDP-514 on Day 1 only (SAD HV), once daily dosing of EDP-514 starting on Day 1 through Day 14 (MAD HV) or once daily dosing of EDP-514 starting on Day 1 through Day 28 (MAD HBV).
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安慰剂比较:EDP-514 HBV MAD Placebo Cohort
Matching placebo, orally, once daily for 28 days
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与 EDP-514 匹配的安慰剂
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
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通过不良事件衡量安全性
大体时间:在 HV SAD 队列中长达 8 天
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在 HV SAD 队列中长达 8 天
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通过不良事件衡量安全性
大体时间:在 HV MAD 队列中长达 21 天
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在 HV MAD 队列中长达 21 天
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Safety measured by adverse events
大体时间:Up to 56 Days in HBV MAD Cohorts
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Up to 56 Days in HBV MAD Cohorts
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次要结果测量
结果测量 |
大体时间 |
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Cmax of EDP-514
大体时间:Up to 6 Days in HV SAD Cohorts
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Up to 6 Days in HV SAD Cohorts
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AUC of EDP-514
大体时间:Up to 6 Days in HV SAD Cohorts
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Up to 6 Days in HV SAD Cohorts
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Cmax of EDP-514
大体时间:Up to 18 Days in HV MAD Cohorts
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Up to 18 Days in HV MAD Cohorts
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AUC of EDP-514
大体时间:Up to 18 Days in HV MAD Cohorts
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Up to 18 Days in HV MAD Cohorts
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EDP-514 的 Cmax
大体时间:在 HBV MAD 队列中长达 28 天
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在 HBV MAD 队列中长达 28 天
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EDP-514 的 AUC
大体时间:在 HBV MAD 队列中长达 28 天
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在 HBV MAD 队列中长达 28 天
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
慢性乙肝病毒感染的临床试验
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National Taiwan University Hospital未知
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Yunnan AIDS Care Center未知
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Shao-quan Zhang未知
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National Institute of Diabetes and Digestive and...招聘中
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Kaohsiung Medical University Chung-Ho Memorial...完全的HBV/HCV 合并感染
EDP-514的临床试验
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Enanta Pharmaceuticals, Inc终止
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Enanta Pharmaceuticals, IncPharmaceutical Research Associates完全的