NCT04971512终止1 期
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-721 in Healthy Subjects (Part 1) and the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of EDP-721 in Combination With EDP-514 in Patients With Chronic Hepatitis B Virus Infection (Part 2)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 26
- 试验地点
- 1
- 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 to evaluate the safety, tolerability, and pharmacokinetics of single and multiple ascending doses of EDP-721 in healthy subjects.
Part 2 is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics and antiviral activity of EDP-721 in combination with EDP-514 in 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
- Double (Participant, 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
- 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.
- •Part 2 (CHB Population)
- •Inclusion Criteria (Nuc-Suppressed CHB Population)
- •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
- •HBsAg detectable in serum/plasma at Screening and in the most recent HBsAg serum/plasma testing at least 6 months previously.
- •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
- •Inclusion Criteria (Viremic CHB Population):
- •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
- •HBsAg detectable in serum/plasma at Screening and in the most recent HBsAg serum/plasma testing at least 6 months previously.
- •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, specifically pegIFN and/or NUC therapy for at least 12 months prior to Screening
- •Exclusion Criteria (Nuc-Suppressed and Viremic CHB Population):
- •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-721 HV SAD Cohorts
Experimental
EDP-721 Dose 1, Dose 2, Dose 3 and Dose 4, in one single administration
干预措施: EDP-721 (Drug)
EDP-721 HV MAD Cohorts
Experimental
EDP-721 Dose 1, Dose 2 and Dose 3, once daily for 14 days
干预措施: EDP-721 (Drug)
EDP-721 HV SAD Placebo Cohort
Placebo Comparator
Matching placebo, in one single administration
干预措施: Placebo (Part 1) (Drug)
EDP-721 HV MAD Placebo Cohort
Placebo Comparator
Matching placebo, once daily for 14 days
干预措施: Placebo (Part 1) (Drug)
EDP-721+ EDP-514 HBV MAD Cohorts
Experimental
EDP-721 once daily for 14 days followed by EDP-721+EDP-514 once daily for 28 days
干预措施: EDP-721 (Part 2) (Drug)
EDP-721+ EDP-514 HBV MAD Cohorts
Experimental
EDP-721 once daily for 14 days followed by EDP-721+EDP-514 once daily for 28 days
干预措施: EDP-514 (Drug)
EDP-721+ EDP-514 HBV MAD Placebo Cohorts
Placebo Comparator
Matching placebo once daily for 42 days
干预措施: Placebo (Part 2) (Drug)
结局指标
主要结局
Safety measured by adverse events
时间窗: Up to 98 Days in Viremic CHB MAD Cohorts
次要结局
- Cmax of EDP-721(Up to 18 Days in HV MAD Cohorts)
- AUC of EDP-721(Up to 18 Days in HV MAD Cohorts)
- Change from baseline in quantitative HBsAg(Through Day 28 in All CHB MAD Cohorts)
- Cmax of EDP-721 alone and in combination with EDP-514(Up to 28 Days in All CHB MAD Cohorts)
- Cmax of EDP-514 in combination with EDP-721(Up to 28 Days in All CHB MAD Cohorts)
- AUC of EDP-721 alone and in combination with EDP-514(Up to 28 Days in All CHB MAD Cohorts)
- AUC of EDP-514 in combination with EDP-721(Up to 28 Days in All CHB MAD Cohorts)
- Change from baseline in HBV DNA Viral Load Assay(Through Day 28 in All CHB MAD Cohorts)
研究者
研究点 (1)
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