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CB06-036 is an investigational drug developed by Shanghai Zhimeng Biopharma Inc. for the treatment of Chronic Hepatitis B.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CB06-036 Cohort 1 | Experimental | 1.5 mg Day1, orally taken in the morning, on an empty stomach. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CB06-036 | Drug | CB06-036 Capsule |
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| Measure | Description | Time Frame |
|---|---|---|
| Abnormalities of vital signs (blood pressure, pulse rate, temperature, and respiration rate) | 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 | At Screening,Baseline,Day1,Day 3 |
| Abnormalities of physical examination | Medical examinations performed by physicians include:Skin, mucous membranes, lymph nodes, head, neck, chest, abdomen, spine and limbs, nervous system | At Screening,Baseline,Day 3 |
| Abnormalities of 12-lead ECG | 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. | At Screening,Baseline,Day1,Day 3 |
| Abnormalities of clinical laboratory | The clinical laboratory items includes:Blood routine, blood biochemistry, urine routine, blood clotting function, A function three, C Reactive protein | At Screening,Baseline,Day 3 |
| Abnormalities of Ophthalmic Examination | 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. | At Screening,Baseline,Day 3 |
| Measure time of the maximum observed concentration 【Tmax】 | To evaluate whether there are differences in the pharmacokinetic characteristics of CB06-036 in healthy subjects in China and the United States |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aiyun Deng | Contact | 15800984667 | adeng@corebiopharma.com |
| Name | Affiliation | Role |
|---|---|---|
| Hong Zhang | The First Hospital of Jilin University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Hospital of Jilin University | Recruiting | Changchun | Jilin | 130000 | China |
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| From 0.5 hour pre-dose to 24 hours post-dose |
| Measure maximum observed concentration【Cmax】 | To evaluate whether there are differences in the pharmacokinetic characteristics of CB06-036 in healthy subjects in China and the United States | From 0.5 hour pre-dose to 24 hours post-dose |
| Measure apparent terminal elimination half-life【t1/2】 | To evaluate whether there are differences in the pharmacokinetic characteristics of CB06-036 in healthy subjects in China and the United States | From 0.5 hour pre-dose to 24 hours post-dose |
| Measure area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-∞) | To evaluate whether there are differences in the pharmacokinetic characteristics of CB06-036 in healthy subjects in China and the United States | From 0.5 hour pre-dose to 24 hours post-dose |
| Measure area under the plasma concentration-time curve from the first dose to the last measurable sample collection time t (AUC 0-t) | To evaluate whether there are differences in the pharmacokinetic characteristics of CB06-036 in healthy subjects in China and the United States | From 0.5 hour pre-dose to 24 hours post-dose |
| Measure Clearance (CL/F) | To evaluate whether there are differences in the pharmacokinetic characteristics of CB06-036 in healthy subjects in China and the United States | From 0.5 hour pre-dose to 24 hours post-dose |
| Measure apparent volume of distribution (Vz/F) | To evaluate whether there are differences in the pharmacokinetic characteristics of CB06-036 in healthy subjects in China and the United States | From 0.5 hour pre-dose to 24 hours post-dose |