NCT07540910招募中1 期
A Randomized, Double-Blind, Sponsor-Open, Placebo-Controlled, First-In-Human, Phase 1 Study of Orally Administered EDP-978 to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses, Multiple Ascending Doses, and the Effect of Food on EDP-978 Pharmacokinetics in Healthy Adult Participants
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Safety measured by adverse events
研究概览
简要总结
This study is a randomized, double-blind, sponsor-open, placebo-controlled study. It will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of orally administered single and multiple doses of EDP-978 in healthy adult 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
- 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.
- •Infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) at screening and infection with SARS-CoV-2 at the Day -1 visit
- •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.
研究组 & 干预措施
EDP-978 MAD Placebo Cohorts
Placebo Comparator
Matching placebo, orally, once daily for 14 days
干预措施: Placebo (Drug)
EDP-978 SAD Cohorts
Experimental
EDP-978 Dose 1, Dose 2, Dose 3, Dose 4, Dose 5, Dose 6 and Dose 7, orally daily in one single administration
干预措施: EDP-978 (Drug)
EDP-978 MAD Cohorts
Experimental
EDP-978 Dose 1, Dose 2, Dose 3, Dose 4 and Dose 5 orally, once daily for 14 days
干预措施: EDP-978 (Drug)
EDP-978 SAD Placebo Cohorts
Placebo Comparator
Matching placebo, orally, once daily in one single administration
干预措施: Placebo (Drug)
结局指标
主要结局
Safety measured by adverse events
时间窗: Up to 28 Days in MAD Cohorts
Safety measured by adverse events
时间窗: Up to 8 Days in SAD Cohorts
次要结局
- Cmax of EDP-978(Up to 5 Days in SAD Cohorts)
- AUC of EDP-978(Up to 5 Days in SAD Cohorts)
- Cmax of EDP-978(Up to 18 Days in MAD Cohorts)
- AUC of EDP-978(Up to 18 Days in MAD Cohorts)
- Cmax of EDP-938 (FE)(Up to 12 Days in FE SAD Cohort)
- AUC of EDP-938 (FE)(Up to 12 Days in FE SAD Cohort)
研究者
研究点 (1)
Loading locations...
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