A Bridging Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CB06-036 in Healthy Subjects in China
- Registration Number
- NCT06101316
- Lead Sponsor
- Shanghai Zhimeng Biopharma, Inc.
- Brief Summary
CB06-036 is an investigational drug developed by Shanghai Zhimeng Biopharma Inc. for the treatment of Chronic Hepatitis B.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 12
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description CB06-036 Cohort 1 CB06-036 1.5 mg Day1, orally taken in the morning, on an empty stomach.
- Primary Outcome Measures
Name Time Method Abnormalities of vital signs (blood pressure, pulse rate, temperature, and respiration rate) 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】 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 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 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 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 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】 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】 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-∞) 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) 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) 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) 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
The First Hospital of Jilin University
🇨🇳Chang chun, Jilin, China