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The purpose of this study is to evaluate the dosages of recombinant human serum albumin/interferon alpha2b fusion protein injection in healthy subjects.
This is an open-label study that will be conducted at a single site in China to characterize the PK/PD profile, safety and tolerability of Recombinant Human Serum Albumin/interferon alpha2b Fusion Protein in healthy subjects. Subjects will receive a single dose of Recombinant Human Serum Albumin/interferon alpha2b Fusion Protein or active comparator Pegasys at Day 0. The total duration of study participation is up to 6 weeks for each subject. Subjects will complete a follow-up visit at Day 28 after the dosing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Human Serum Albumin/interferon alpha2b | Experimental | Human Serum Albumin/interferon alpha2b fusion protein 300-1200 μg single dose S.C. |
|
| Pegasys | Active Comparator | Peginterferon 180 μg single dose S.C. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Human Serum Albumin/interferon alpha2b | Biological | Human Serum Albumin/interferon alpha2b fusion protein 300-1200 μg single dose S.C. at Day0 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events after single dose | Frequency and severity of all adverse events on the part of the participants, including frequency and severity of drug-related adverse events. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of interferon after single dose | Peak plasma concentration(Cmax) | 4 weeks |
| Pharmacokinetics of interferon after single dose | Area under the plasma concentration versus time curve (AUC) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Meixia Wang, Professor | Beijing YouAn Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing YouAn Hospital, Capital Medical University | Beijing | Beijing Municipality | 100069 | China |
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| ID | Term |
|---|---|
| D000075462 | Serum Albumin, Human |
| D007438 | Introns |
| ID | Term |
|---|---|
| D012709 | Serum Albumin |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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| Peginterferon 180 μg single dose S.C. | Biological | Pegasys 180 mcg S.C. single dose on Day 0 |
|
| 4 weeks |
| Plasma concentration of Neopterin after single dose | Plasma concentration of Neopterin after single dose | 4 weeks |
| Pharmacokinetics of interferon after single dose | Peak time(Tmax) | 4 weeks |
| Pharmacokinetics of interferon after single dose | Half-life period(T1/2) | 4 weeks |
| D001798 |
| Blood Proteins |
| D021901 | DNA, Intergenic |
| D040481 | Genome Components |
| D016678 | Genome |
| D040342 | Genetic Structures |
| D055614 | Genetic Phenomena |
| D040461 | Gene Components |
| D005796 | Genes |