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A Pharmacokinetic and Safety Study of MY008211A Tablets in Subjects With Impaired or Normal Hepatic Function

This study is a single-center, non-randomized, open-label, parallel, single-dose study to evaluate the PK profile and safety of MY008211A Tablets in subjects with hepatic impairment.

研究概览

详细说明

This study is a single-center, non-randomized, open-label, parallel, single-dose study to evaluate the PK profile and safety of MY008211A Tablets in subjects with hepatic impairment.

It is planned to enroll 24 subjects, male or female. A total of 3 treatment groups will be set up: normal hepatic function group, mild hepatic impairment (Child-Pugh A) group, moderate hepatic impairment (Child-Pugh B) group, with 8 subjects in each group. Each subject will take a single oral dose of 400 mg MY008211A Tablets under fasting conditions.

This study will first enroll subjects in Group A (mild hepatic impairment) and Group B (moderate hepatic impairment). Age, gender and body weight will not be matched between subjects in Groups A and B; after enrollment for Groups A and B is completed, subjects will be enrolled in Group C (normal hepatic function) as control subjects matched with the hepatic impairment subjects (Group A + Group B):

Subjects who sign the informed consent form (ICF) will be screened according to the inclusion/exclusion criteria. Eligible subjects will be admitted to the Clinical Research Unit (CRU) on Day -1 (D-1). On D1, they will take a single oral dose of 400 mg MY008211A Tablets under fasting conditions and will be discharged after completing the observations and drop-out examinations on D4. They will receive a telephone follow-up on D11.

During the study, sample collection, recording of adverse events (AEs), concomitant medication/non-drug therapy, physical examination, vital signs, ECG, and clinical laboratory tests will be performed according to the protocol requirements.

研究类型

介入性

注册 (实际的)

24

阶段

  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Changchun
      • Jilin City、Changchun、中国、130000
        • The First Hospital of Jilin University

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Voluntarily participate in the clinical study and sign the written ICF, be able to understand the procedures and methods of this study, and be able to complete the entire study process according to the study requirements;
  • Age 18 to 70 years (inclusive) on the day of signing the ICF, male or female;
  • Body weight: ≥ 50 kg for males, ≥ 45 kg for females; body mass index (BMI): 18.0-32.0 kg/m2 (both inclusive);
  • Subjects (including their partners) have no birth plan from screening until 3 months after the administration of the investigational product and voluntarily take contraceptive measures, and have no plans to donate sperm or eggs;
  • Glomerular filtration rate (calculated using the CKD-EPI formula) ≥ 60 mL/min;

Exclusion Criteria:

  • Known or suspected history of immunodeficiency (e.g., history of frequent recurrent infections), hereditary or acquired complement deficiency;
  • Clear history of capsular microbial infection within 6 months before screening, including but not limited to Streptococcus pneumoniae, Bacillus anthracis, Salmonella, Salmonella typhi, Klebsiella pneumoniae, Pseudomonas aeruginosa, Bacteroides fragilis, Neisseria meningitidis, Haemophilus influenzae and Legionella pneumophila.
  • Subjects who have a previous history of tuberculosis infection or are currently suffering from tuberculosis infection;
  • Active systemic bacterial, viral or fungal infections within 14 days before administration;
  • Fever (≥ 38°C) within 7 days before administration;
  • Subjects suspected of having a history of allergy to any component of the investigational product, or with allergic constitution (allergic to multiple drugs and foods, and judged by the investigator to be clinically significant);
  • Those who have previously undergone surgery that, as judged by the investigator, will affect drug absorption, distribution, metabolism and excretion; or those who have undergone surgery within 4 weeks prior to screening; or those who plan to undergo surgery during the study;
  • Those who cannot tolerate venipuncture or with a history of blood phobia and acupuncture syncope;

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:非随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:normal hepatic function group
Each subject will take a single oral dose of 400 mg MY008211A Tablets under fasting conditions.
Each subject will take a single oral dose of 400 mg MY008211A Tablets under fasting conditions.
实验性的:mild hepatic impairment (Child-Pugh A) group
Each subject will take a single oral dose of 400 mg MY008211A Tablets under fasting conditions.
Each subject will take a single oral dose of 400 mg MY008211A Tablets under fasting conditions.
实验性的:moderate hepatic impairment (Child-Pugh B) group
Each subject will take a single oral dose of 400 mg MY008211A Tablets under fasting conditions.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Cmax
大体时间:up to 12 weeks
maximum concentration
up to 12 weeks
AUC0-last
大体时间:up to 12 weeks
area under the plasma concentration-time curve from 0 to the last quantifiable time point
up to 12 weeks
AUC0-inf
大体时间:up to 12 weeks
area under the plasma concentration-time curve from 0 to infinity
up to 12 weeks

次要结果测量

结果测量
措施说明
大体时间
Tmax
大体时间:up to 12 weeks
time to reach maximum concentration
up to 12 weeks
CL/F
大体时间:up to 12 weeks
apparent clearance
up to 12 weeks
Vz/F
大体时间:up to 12 weeks
apparent volume of distribution
up to 12 weeks
t1/2
大体时间:up to 12 weeks
terminal half-life
up to 12 weeks
body temperature
大体时间:up to 12 weeks
Measure the body temperature of the subjects, using degrees Celsius as the unit.
up to 12 weeks
IU/L or mIU/mL of HCG in the blood of reproductive-aged women
大体时间:up to 12 weeks
The blood human chorionic gonadotropin (HCG) pregnancy test will measure the concentration of HCG in the blood of reproductive-aged women to determine if they are pregnant. The units in the report will be presented in IU/L (international units per liter) and/or mIU/mL.
up to 12 weeks
12-lead ECG
大体时间:up to 12 weeks
Evaluate QT interval, PR interval, etc.
up to 12 weeks
adverse events and serious adverse events
大体时间:up to 12 weeks
up to 12 weeks
Pulse
大体时间:up to 12 weeks
Measure the pulse of the subjects, expressing it in units of beats per minute.
up to 12 weeks
Blood pressure
大体时间:up to 12 weeks
Measure the systolic and diastolic blood pressure of the subjects, with the unit of mm/hg.
up to 12 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:YaNan Wang, PHD、The First Hospital of Jilin University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年9月20日

初级完成 (实际的)

2024年12月28日

研究完成 (实际的)

2024年12月28日

研究注册日期

首次提交

2026年5月9日

首先提交符合 QC 标准的

2026年5月28日

首次发布 (实际的)

2026年6月4日

研究记录更新

最后更新发布 (实际的)

2026年6月4日

上次提交的符合 QC 标准的更新

2026年5月28日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • MY008211-1-09

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

The company's business decision

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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