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Phase 1 Study of BW-20507 in Healthy Subjects and Patients With Chronic Hepatitis B. Ia involved a single ascending dose study where healthy participants were administered one dose of BW-20507 or placebo subcutaneously. Ib involved a multiple ascending dose study where participants with chronic hepatitis B virus infection were administered with multiple doses of BW-20507 SC
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ia | Experimental |
| |
| Ib | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Solution for injection |
| |
| BW-20507 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with adverse events (AEs) and serious adverse events (SAEs) | Up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| AUC: The area under the BW-20507 plasma concentration-time curve | Measured in hours*nanograms per milliliter | Up to 12 weeks |
| Cmax: The maximum concentration of BW-20507 in plasma | Measured in nanograms per milliliter (ng/mL). |
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Inclusion Criteria:
Ia:
Exclusion Criteria:
Ia
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Argo Investigative Site | Beijing | Beijing Municipality | 100050 | China | ||
| Argo Investigative Site |
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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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| Drug |
Solution for injection |
|
| Up to 12 weeks |
| Tmax: The time from dosing to maximum plasma concentration of BW -20507 | Measured in hours. | Up to 12 weeks |
| T1/2: Terminal half-life for BW -20507 after dosing | Measured in hours. | Up to 12 weeks |
| HBsAg level change from baseline | Measured in IU/mL | Up tp 48 weeks |
| Chongqing |
| Chongqing Municipality |
| 404000 |
| China |
| Argo Investigative Site | Guanzhou | Guangdong | 510700 | China |
| Argo Investigative Site | Xuzhou | Jiangsu | 221000 | China |
| 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 |