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| Name | Class |
|---|---|
| Peking University First Hospital | OTHER |
| Beijing Clinical Service Center | OTHER |
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The objective of this study is to evaluate the safety and efficacy of ASC22 in the treatment of chronic hepatitis B after single and multiple drug administration.
The study consists of two parts: the ASC22 single-dose IIa study and the ASC22 multi-dose IIb study. The IIa study consists of 3 cohorts of 0.3mg/kg, 1.0mg/kg and 2.5mg/kg, and the IIb study consists of 2 cohorts of 1.0mg/kg and 2.5mg/kg. The objective is to evaluate the safety, tolerance and efficacy of ASC22 in patients with chronic hepatitis B (CHB), and to provide a guidance for the determination of dosage regimen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cohort1: Single dose ASC22 injection 0.3mg/kg | Experimental | Single dose ASC22 Injection; Specification: 200mg/1ml/1bottle; Subcutaneous injection; once administration,0.3mg/kg dose of the drug once. |
|
| cohort2:Single dose ASC22 injection 1.0mg/kg | Experimental | Single dose ASC22 Injection; Specification: 200mg/1ml/1bottle; Subcutaneous injection; once administration,1.0mg/kg dose of the drug once. |
|
| cohort3:Single dose ASC22 injection 2.5mg/kg | Experimental | Single dose ASC22 Injection; Specification: 200mg/1ml/1bottle; Subcutaneous injection; once administration,2.5mg/kg dose of the drug once. |
|
| cohort4: Multiple dose ASC22 injection 1.0mg/kg | Experimental | Multiple dose ASC22 injection; Specification: 200mg/1ml/1bottle; Subcutaneously administered once every 2 weeks , 4 received 1.0mg/kg, up to 24 weeks |
|
| cohort5: Multiple dose ASC22 injection 2.5mg/kg | Experimental | Multiple dose ASC22 injection; Specification: 200mg/1ml/1bottle; Subcutaneously administered once every 2 weeks , 4 received 2.5mg/kg, up to 24 weeks |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASC22 | Drug | 200mg/1ml/1bottle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the decreased HBsAg levels at 12 or 24 weeks of treatment or at 4, 12, or 24 weeks of follow-up visits compared with baseline. | Each multiple dose cohort will last 48 weeks (24-weeks treatment plus 24-weeks follow up). | 48 weeks |
| Evaluate the number of patients with ≥0.5log reduction in HBsAg log10IU/ mL at 12 or 24 weeks of treatment, or at 4, 12, or 24 weeks of follow-up visits compared with baseline. | Each multiple dose cohort will last 48 weeks (24-weeks treatment plus 24-weeks follow up). | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the decline value of HBsAg level. | Each multiple dose cohort will last 48 weeks (24-weeks treatment plus 24-weeks follow up). | 48 weeks |
| Evaluate the propotion's change of HBsAg < 0.05IU/ml in each cohort. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Beijing | China |
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| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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|
| cohort4: Placebo sodium chloride injection A | Placebo Comparator | Placebo saline injection; Specification: 90mg/10ml/1 bottle; Subcutaneously administered every 2 weeks (Q2W, known as one drug administration cycle), duration: once every 2 weeks (Q2W), up to 12 weeks. Based on the weight of the patients, an equal dose of placebo was administered according to the incoming dose group (1.0mg/kg). |
|
| cohort5: Placebo sodium chloride injection B | Placebo Comparator | Placebo saline injection; Specification: 90mg/10ml/1 bottle; Subcutaneously administered every 2 weeks (Q2W, known as one drug administration cycle), duration: once every 2 weeks (Q2W), up to 12 weeks. Based on the weight of the patients, an equal dose of placebo was administered according to the incoming dose group (2.5mg/kg). |
|
| cohort6: Multiple dose ASC22 injection 1.0mg/kg | Experimental | Multiple dose ASC22 injection; Specification: 200mg/1ml/1bottle; Subcutaneously administered once every 2 weeks , 4 received 1.0mg/kg, up to 24 weeks |
|
| cohort6: Placebo sodium chloride injection A | Placebo Comparator | Placebo saline injection; Specification: 90mg/10ml/1 bottle; Subcutaneously administered every 2 weeks (Q2W, known as one drug administration cycle), duration: once every 2 weeks (Q2W), up to 12 weeks. Based on the weight of the patients, an equal dose of placebo was administered according to the incoming dose group (1.0mg/kg). |
|
| sodium chloride | Drug | 90mg/10ml/1 bottle |
|
Each multiple dose cohort will last 48 weeks (24-weeks treatment plus 24-weeks follow up).
| 48 weeks |
| Evaluate the changes of cytokines (IL-2, IFN-γ) in each cohort. | Each multiple dose cohort will last 48 weeks (24-weeks treatment plus 24-weeks follow up). | 48 weeks |
| Evaluate the changes of peripheral blood lymphocyte subsets in each cohort. | Each multiple dose cohort will last 48 weeks (24-weeks treatment plus 24-weeks follow up). | 48 weeks |
| D018347 |
| Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017670 |
| Sodium Compounds |