NCT06577415招募中1 期
A Single Dose Pharmacokinetic Study of ray1225 in Subjects With Varying Degrees of Hepatic Impairment
Guangdong Raynovent Biotech Co., Ltd1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2024年8月26日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Pharmacokinetics (PK): Area Under The Drug Concentration-Time Curve From Zero To Infinity (AUC[0-∞]) of RAY1225
研究概览
简要总结
The purpose of this study is to assess how fast RAY1225 gets into the blood stream and how long it takes the body to remove it in participants with impaired liver function compared to healthy participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant must be ≥ 18 to ≤ 75 years;
- •BMI ≥ 20 kg/m2 up to ≤ 32 kg/m2;
- •Participants (including partners) must use reliable methods of contraception during the study and until 6 months following the last dose of investigational product;
- •Signature of a dated Informed Consent Form (ICF) indicating that the participates has been informed of all the relevant aspects(including adverse events) of the trial prior to enrollment;
- •eGFR ≥ 60 mL/min/1.73 m2;
- •Participants with Normal Hepatic Function Only:
- •Healthy males or females as determined by medical history, physical examination, and other screening procedures, with normal liver function;
- •Participants with hepatic impairment only:
- •Males or females with chronic mild and moderate liver impairment, assessed by Child-Pugh scoring.
排除标准
- •Participants with an allergic disposition (multiple drug and food allergies) or who, as determined by the investigator, are likely to be allergic to the investigational drug product or any component of the investigational drug product;
- •QTcF> 450ms;
- •Participants with serious infections, trauma, gastrointestinal surgery or other major surgical procedures within 4 weeks;
- •Participates who donated blood or bleeding profusely (> 400 mL) in the 3 months;
- •Pregnant or lactating women, or women of childbearing age with a positive pregnancy test;
- •Smoking averaged more than 10 cigarettes per day in the 3 months prior to screening;
- •Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2;
- •Participants with Normal Hepatic Function Only:
- •Any history of hepatic impairment, or potential presence of liver function impairment by physical examination and laboratory examination at screening.
- •Participants with Hepatic Impairment Only:
- •Any history of clinically serious illness or disease or condition except for primary liver disease that the investigator believes may affect the results of the trial, including but not limited to a history of circulatory, endocrine, nervous, digestive, urinary, respiratory or hematological, immune, psychiatric, and metabolic disorders.
- •Participants with drug-induced liver injury; history of liver transplantation; cirrhosis in combination with the following complications: including but not limited to liver failure, hepatic encephalopathy, hepatocellular carcinoma, esophageal bleeding from ruptured fundic varices.
研究组 & 干预措施
Mild Hepatic Impairment
Experimental
Participants with mild hepatic impairment received single subcutaneous dose of 3 milligrams (mg) RAY1225.
干预措施: RAY1225 (Drug)
Moderate Hepatic Impairment
Experimental
Participants with moderate hepatic impairment received single subcutaneous dose of 3 mg RAY1225.
干预措施: RAY1225 (Drug)
Normal Hepatic Function
Active Comparator
Participants with normal hepatic function received single subcutaneous dose of 3 mg RAY1225.
干预措施: RAY1225 (Drug)
结局指标
主要结局
Pharmacokinetics (PK): Area Under The Drug Concentration-Time Curve From Zero To Infinity (AUC[0-∞]) of RAY1225
时间窗: DAY1~43
Pharmacokinetics (PK): Area Under The Drug Concentration-Time Curve From Zero To Infinity (AUC\[0-∞\]) of RAY1225.
PK: Maximum Observed Drug Concentration (Cmax) of RAY1225
时间窗: DAY1~43
PK: Maximum Observed Drug Concentration (Cmax) of RAY1225
次要结局
- Number of participants with drug-related adverse events as assessed by CTCAE v5.0(DAY1~43)
研究者
研究点 (1)
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