A Pharmacokinetic and Safety Study of MY008211A Tablets in Subjects With Impaired or Normal Hepatic Function
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
排除标准
- •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;
研究组 & 干预措施
normal hepatic function group
Each subject will take a single oral dose of 400 mg MY008211A Tablets under fasting conditions.
干预措施: MY008211A tablets (Drug)
mild hepatic impairment (Child-Pugh A) group
Each subject will take a single oral dose of 400 mg MY008211A Tablets under fasting conditions.
干预措施: MY008211A tablets (Drug)
moderate hepatic impairment (Child-Pugh B) group
干预措施: MY008211A tablets (Drug)
结局指标
主要结局
Cmax
时间窗: up to 12 weeks
maximum concentration
AUC0-last
时间窗: up to 12 weeks
area under the plasma concentration-time curve from 0 to the last quantifiable time point
AUC0-inf
时间窗: up to 12 weeks
area under the plasma concentration-time curve from 0 to infinity
次要结局
- Tmax(up to 12 weeks)
- adverse events and serious adverse events(up to 12 weeks)
- CL/F(up to 12 weeks)
- Vz/F(up to 12 weeks)
- t1/2(up to 12 weeks)
- body temperature(up to 12 weeks)
- IU/L or mIU/mL of HCG in the blood of reproductive-aged women(up to 12 weeks)
- 12-lead ECG(up to 12 weeks)
- Pulse(up to 12 weeks)
- Blood pressure(up to 12 weeks)