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This study is aimed to study the pharmacokinetic characteristics(e.g. AUC, Cmax, Tmax) of Ypeginterferon alfa-2a and interferon biomarkers(e.g. 2,5-OAS, neopterin) after single dose at different levels.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Other |
| |
| Arm 2 | Other |
| |
| Arm 3 | Other |
| |
| Arm 4 | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peginterferon alfa | Drug | s,c, 45mcg of Ypeginterferon alfa-2a |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Measuring interferon levels in blood samples | from 0 to 408 hours following injection | |
| Different blood interferon biomarkers (such as 2,5-OAS, neopterin) | from 0 to 408 hours following injection |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | up to 3 weeks following injection | |
| Anti-interferon antibody | baseline and week 2 after injection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wei Zhenman, Ph.D | Beijing 302 Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 302 Military Hospital of China | Beijing | 100039 | China |
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| Peginterferon alfa 2a |
| Drug |
s,c, 90mcg of Ypeginterferon alfa-2a or 180mcg of Pegasys. |
|
| Peginterferon alfa-2a | Drug | s,c, 180mcg of Ypeginterferon alfa-2a or 180mcg of Pegasys. |
|
| Peginterferon alfa-2a | Drug | s,c, 270mcg of Ypeginterferon alfa-2a or 180mcg of Pegasys. |
|
| ID | Term |
|---|---|
| C100416 | peginterferon alfa-2a |
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