NCT05022693已完成1 期
An Open-Label, Single-Dose Pharmacokinetic Study of Liquid Subcutaneous Formulation of BIO89-100 in Subjects With Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 89bio, Inc.
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- PK Profile of liquid formulation of BIO89-100
研究概览
简要总结
This is an open-label, single-dose study to evaluate the PK profile of the liquid SC formulation of BIO89-100 in approximately 8 male and female subjects with NASH with compensated cirrhosis.
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
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 21 to 65
- •Diagnosis of NASH with compensated cirrhosis by a hepatologist based on Liver Forum criteria.
- •Model for End-Stage Liver Disease (MELD) score <
- •Child-Turcotte-Pugh (CTP) score < 7 (Class A).
- •Fibrosis stage F4 by FibroScan.
排除标准
- •History of hepatic cirrhosis decompensation, OR overt hepatic encephalopathy OR signs of hepatic cirrhosis decompensation.
- •Prior transjugular intrahepatic portosystemic (TIPS) shunt procedure.
- •known condition other than cirrhosis that may possibly interfere with drug absorption, distribution, metabolism, or excretion.
- •Significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to screening.
研究组 & 干预措施
BIO89-100 30 mg, Open Lable, Single Dose
Experimental
干预措施: BIO89-100 (Drug)
结局指标
主要结局
PK Profile of liquid formulation of BIO89-100
时间窗: 22 days
Area under the serum drug concentration-by-time curve from time 0 to the time of the last quantifiable drug concentration (AUC0-t)
次要结局
- Evaluate the safety and tolerability of the BIO89-100 liquid formulation(22 days)
研究者
研究点 (1)
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