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The study is being conducted to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS-5635 in healthy adults and chronic hepatitis B. To explore the reasonable dosage of HRS-5635.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 | Experimental | Single Dose Incremental (SAD) Trial - Healthy Persons:HRS-5635 vs. Placebo |
|
| Part 2a | Experimental | Multiple Dose Increase (MAD) Study - Patients Receiving Consolidation Therapy:HRS-5635 vs. Placebo |
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| Part 2b | Experimental | Patients not receiving consolidation treatment:HRS-5635 vs. Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-5635 | Drug | 50mg HRS-5635;100mg HRS-5635;200mg HRS-5635;400mg HRS-5635;600mg HRS-5635;800mg HRS-5635 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Events In Part 1 | A summary of adverse events, including Serious Adverse Events(SAEs) | 85 days |
| Number of Adverse Events In Part 2 | A summary of adverse events, including Serious Adverse Events(SAEs) | 169 days |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) of single dose | 8 days | |
| Peak Plasma Concentration (Cmax) of Multiple ascending dose | 64 days | |
| Time to the peak plasma concentration (Tmax) of single dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guangming Feng | Contact | +0518-82342973 | guangming.feng@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of China University of Science and Technology | Recruiting | Hefei | Anhui | 230001 | China |
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| HRS-5635 | Drug | 100mg HRS-5635,Q4W;200mg HRS-5635 ,Q4W;400mg HRS-5635,Q4W;200mg HRS-5635, Q2W |
|
| HRS-5635 | Drug | 200mg HRS-5635,Q4W |
|
| Placebo | Drug | Placebo |
|
| 8 days |
| Time to the peak plasma concentration (Tmax) of Multiple ascending dose | 64 days |
| 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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