A Bridging Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CB06-036 in Healthy Subjects in China
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Abnormalities of vital signs (blood pressure, pulse rate, temperature, and respiration rate)
研究概览
简要总结
CB06-036 is an investigational drug developed by Shanghai Zhimeng Biopharma Inc. for the treatment of Chronic Hepatitis B.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able to provide signed informed consent to participate in the study and understand the study content, procedures, and possible adverse reactions.
- •Able to finish the study in accordance with the study protocol.
- •Subjects (including partners) are willing to voluntarily take effective contraceptive measures within 6 months from screening until the last dose of the study drug (see Appendix 4 for specific contraceptive measures)
- •Male or Female, of age ≥18 and ≤50 years.
- •Body weight ≥50.0 kg for males and ≥45.0 kg for females, with BMI ≥ 18 and ≤ 28 kg/m2, BMI ＝ Body Weight (kg) / Height 2(m2).
- •No clinically significant abnormal finding on vital signs or physical examination at screening.
- •Estimated Glomerular Filtration Rate (eGFR) ≥ 60 mL/min calculated using the Modification of Diet in Renal Disease (Cockcroft-Gault MDRD) equations (see Appendix 6 for the details);
- •Liver function tests within the normal range for alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, and total bilirubin at screening.
排除标准
- •Having had major trauma or underwent major surgery within 3 months before screening.
- •With previous treatment, which may affect drug absorption (such as subtotal gastrectomy).
- •History of blood donation or massive blood loss (> 450 mL) within 3 months before screening.
- •Suspected of having a history of allergy to any ingredient of the study drug or allergic constitution (multiple drug and food allergy).
- •Smoked more than 5 cigarettes per day within 1 month before screening.
- •History of drug abuse and/or alcohol abuse (alcohol use exceeds 14 units per week; 1 unit = 285 mL of beer, or 100 mL of wine, or 25 mL of distilled alcohol).
- •Acute infections within 14 weeks before screening.
- •Clinically significant abnormalities on clinical laboratory tests or other clinical findings within 6 months prior to screening that indicates clinically significant disease of the following (including, but not limited to, gastrointestinal, renal, hepatic, neurological, hematological, endocrine, oncological, pulmonary, immunological, psychiatric, or cardiovascular disease);
- •Have known or historically documented uveitis, systemic lupus erythematosus, rheumatoid arthritis, psoriasis, Sjogren's syndrome, scleroderma, and other autoimmune diseases.
- •Have known or documented history of clinically significant fundus lesions (symptomatic fundus cotton-wool-spots) and retinopathy;
- •Have a known or documented history of clinically significant thyroid disease;
- •History of myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG), Grade III or IV heart failure, or stroke within 6 months before screening.
- •Plan to have surgery or be hospitalized during the study.
- •Have used immunosuppressants, immunomodulators (thymosin), and cytotoxic drugs within 6 months before screening;
- •Use of a class of drugs with a defined action that serves as moderately potent inhibitors or strong inducers, which can alter the activity of drug-metabolizing enzymes, etc., within 14 days before screening;
- •Have used any prescription drugs, over-the-counter drugs, vitamins, herbal or other diet or supplement deemed inappropriate by the Investigator within 7 days prior to screening;
- •Those who have been vaccinated within 14 days prior to screening or plan to be vaccinated during the study;
- •Those who have consumed a special diet (including dragon fruit, mango, grapefruit, etc.) or exercised vigorously within 3 days before screening, or have other factors that affect drug absorption, distribution, metabolism, excretion, etc.;
- •Having had chocolate, caffeine or xanthine-rich food or beverage, or any alcohol products 48 hours before study drug administration.
- •Have acute illness or using concomitant medication from screening to study drug administration;
- •Have had any investigational medicine or participated in the clinical study of medical devices within 3 months before screening.
- •With clinically significant ECG abnormalities judged by the investigator as not suitable for study participation.
- •Women of breast-feeding or with positive pregnancy test.
- •Positive screening for any of Hepatitis B serological test, hepatitis C[HCV] antibodies, Human immunodeficiency Virus[HIV], or Syphilis test.
- •Positive urine drug screen (morphine, marijuana) or alcohol breath test.
- •Have other factors that are not suitable for study participation in the investigator's opinion.
研究组 & 干预措施
CB06-036 Cohort 1
1.5 mg Day1, orally taken in the morning, on an empty stomach.
干预措施: CB06-036 (Drug)
结局指标
主要结局
Abnormalities of vital signs (blood pressure, pulse rate, temperature, and respiration rate)
时间窗: At Screening，Baseline，Day1，Day 3
Vital signs safe reference range:systolic blood pressure 84-139 mmHg, diastolic blood pressure 50-89 mmHg, pulse rate 50-100 times per min, temperature 35.9-37.6℃, respiration rate 12-20 times per min
Measure time of the maximum observed concentration 【Tmax】
时间窗: From 0.5 hour pre-dose to 24 hours post-dose
To evaluate whether there are differences in the pharmacokinetic characteristics of CB06-036 in healthy subjects in China and the United States
Abnormalities of physical examination
时间窗: At Screening，Baseline，Day 3
Medical examinations performed by physicians include:Skin, mucous membranes, lymph nodes, head, neck, chest, abdomen, spine and limbs, nervous system
Abnormalities of 12-lead ECG
时间窗: At Screening，Baseline，Day1，Day 3
An ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTcF intervals should be used. Changes in T-wave, U-wave morphology and overall ECG interpretation will be documented.
Abnormalities of clinical laboratory
时间窗: At Screening，Baseline，Day 3
The clinical laboratory items includes：Blood routine, blood biochemistry, urine routine, blood clotting function, A function three, C Reactive protein
Abnormalities of Ophthalmic Examination
时间窗: At Screening，Baseline，Day 3
Ophthalmic examinations will be performed to assess ophthalmologic findings, including direct/indirect ophthalmologic examination, slit lamp and fundoscopic examination with retinal photographs (both eyes).Photographs of the retina must be taken.
Measure maximum observed concentration【Cmax】
时间窗: From 0.5 hour pre-dose to 24 hours post-dose
To evaluate whether there are differences in the pharmacokinetic characteristics of CB06-036 in healthy subjects in China and the United States
Measure apparent terminal elimination half-life【t1/2】
时间窗: From 0.5 hour pre-dose to 24 hours post-dose
To evaluate whether there are differences in the pharmacokinetic characteristics of CB06-036 in healthy subjects in China and the United States
Measure area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-∞)
时间窗: From 0.5 hour pre-dose to 24 hours post-dose
To evaluate whether there are differences in the pharmacokinetic characteristics of CB06-036 in healthy subjects in China and the United States
Measure area under the plasma concentration-time curve from the first dose to the last measurable sample collection time t (AUC 0-t)
时间窗: From 0.5 hour pre-dose to 24 hours post-dose
To evaluate whether there are differences in the pharmacokinetic characteristics of CB06-036 in healthy subjects in China and the United States
Measure Clearance (CL/F)
时间窗: From 0.5 hour pre-dose to 24 hours post-dose
To evaluate whether there are differences in the pharmacokinetic characteristics of CB06-036 in healthy subjects in China and the United States
Measure apparent volume of distribution (Vz/F)
时间窗: From 0.5 hour pre-dose to 24 hours post-dose
To evaluate whether there are differences in the pharmacokinetic characteristics of CB06-036 in healthy subjects in China and the United States
次要结局
未报告次要终点