NCT05118516已完成1 期
A Phase 1, Open-label, Single-dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ASC43F, a Fixed-dose Combination (FDC) Oral Tablet Containing ASC41, a THR β Agonist and ASC42, an FXR Agonist in Healthy Subjects
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
- 8
- 试验地点
- 1
- 主要终点
- Safety and tolerability of ASC43F evaluated by incidence of treatment emergent adverse events (TEAEs).
研究概览
简要总结
This is a phase 1, open-label study in healthy adults. This study is aimed at evaluating the safety, tolerability, and pharmacokinetics of ASC43F, a fixed-dose combination (FDC) and single dose tablet containing ASC41, a THR β agonist and ASC42, an FXR agonist in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Healthy male and female subjects between 18 to 65 years of age.
- •Subjects must weigh at least 50 kg (110 pounds [lbs.]) for men, and at least 45 kg (99 lbs.) for women and body mass index (BMI) within the range 18.5-32 kilogram per meter square (kg/m2).
- •Physical examination and vital signs are within normal range or slightly abnormal.
排除标准
- •Any surgical or medical condition which in the opinion of the investigator, might significantly alter the absorption, distribution, metabolism, or excretion of drugs.
- •Abnormal clinical or laboratory findings that indicate diseases including but not limited to renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic disease.
- •History or current electrocardiogram (ECG) abnormalities, arrhythmias or heart valve diseases.
- •History of viral hepatitis or HIV
- •History of drug or food allergies that caused severe hypersensitivity reactions or anaphylaxis.).
研究组 & 干预措施
Experimental
Experimental
ASC43F for all subjects under the fasted state.
干预措施: ASC43F (Drug)
结局指标
主要结局
Safety and tolerability of ASC43F evaluated by incidence of treatment emergent adverse events (TEAEs).
时间窗: Baseline to day 7
次要结局
- To evaluate the pharmacokinetics as assessed by Cmax (Max Concentration) of ASC43F tablet following a single fixed oral dose in healthy subjects(Baseline to day 4)
- To evaluate the pharmacokinetics as assessed by Area Under the Curve (AUC) of ASC43F tablet following a single fixed oral dose in healthy subjects(Baseline to day 4)
- To evaluate the pharmacokinetics as assessed by Tmax (Time to Max Concentration) of ASC43F tablet following a single fixed oral dose in healthy subjects(Baseline to day 4)
研究者
研究点 (1)
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