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The Safety, Tolerability, Pharmacokinetics and antiviral activity Study of Anti hepatitis B virus treatment drug Freethiadine in Healthy subjects and in patients with chronic hepatitis B
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Freethiadine tablets | Experimental | part 1(Health volunteer): single-Dose Study: There will be a total of 5 dose cohorts: 5 mg、10 mg、200 mg(food effect)、400 mg、600 mg; multiple-dose study: 100 mg、200 mg、300 mg、150 mg |
|
| Freethiadine placebo tablets | Placebo Comparator | part 1(Health volunteer): single-Dose Study: There will be a total of 5 dose cohorts: 5 mg、10 mg、200 mg(food effect)、400 mg、600 mg; multiple-dose study: 100 mg、200 mg、300 mg、150 mg |
|
| Freethiadine tablet | Experimental | part 2(Patients with chronic hepatitis B): There will be a total of 4 dose cohorts:100 mg、200 mg(BID or QD)、300 mg |
|
| entecavir tablets | Active Comparator | part 2(Patients with chronic hepatitis B): 0.5 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Freethiadine tablets(part I) | Drug | Subjects will receive either a single dose of Freethiadine on Day 1 only (SAD HV), twice daily dosing of Freethiadine starting on Day 1 through Day 10 (MAD HV) |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Incidence of adverse events | From Days 1-35 |
| AUC | Maximum plasma concentration of study drugs | Day 1-12 |
| HBV DNA | Change from baseline in HBV DNA | Day 1-35 |
| Measure | Description | Time Frame |
|---|---|---|
| HBsAg | Change from baseline in HBsAg | Day 1-35 |
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Inclusion Criteria:
Health volunteer:
Patients with chronic hepatitis B:
Exclusion Criteria:
Health volunteer:
Patients with chronic hepatitis B:
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| Name | Affiliation | Role |
|---|---|---|
| JinLin Hou, Doctor | Southern Hospital of Southern Medical University | Principal Investigator |
| JunQI Niu, Doctor | The First Hospital of Jilin University | Principal Investigator |
| Yanhua Ding, Doctor | The First Hospital of Jilin University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southern Hospital of Southern Medical University | Guangzhou | Guangdong | 510000 | China | ||
| The First Hospital of Jilin University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39673713 | Derived | Li X, Xu J, Sun J, Liu J, Wu M, Zhang H, Zhu X, Li C, Zhang Y, Zhu J, Chen Y, Luo L, He Q, Zhuang Y, Chen Y, Niu J, Ding Y. Safety, Pharmacokinetics and Antiviral Efficacy of Capsid Assembly Modulator Freethiadine in Healthy Volunteers and Chronic Hepatitis B Patients. Liver Int. 2025 Jan;45(1):e16213. doi: 10.1111/liv.16213. |
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| Freethiadine tablets (part II) | Drug | once or twice daily for consecutive 28 days |
|
| Freethiadine placebo tablets | Drug | Subjects will receive either a single dose of Freethiadine on Day 1 only (SAD HV), twice daily dosing of Freethiadine starting on Day 1 through Day 10 (MAD HV) |
|
| entecavir tablets | Drug | once daily for consecutive 28 days |
|
| Changchun |
| Jilin |
| 130000 |
| China |
| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| 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 |
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| ID | Term |
|---|---|
| C413685 | entecavir |
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