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This study will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of Recombinant Human Serum Albumin/interferon alpha2a Fusion Protein single dose in Chinese healthy volunteers.
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 alpha2a Fusion Protein in healthy subjects. Subjects will receive a single dose of Recombinant Human Serum Albumin/interferon alpha2a 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 alpha2a | Experimental | Human Serum Albumin/interferon alpha2a 300-1200 mcg single dose S.C. |
|
| Pegasys | Active Comparator | Peginterferon 180 mcg single dose S.C. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Human Serum Albumin/interferon alpha2a 300-1200 mcg single dose S.C. | Biological | Recombinant Human Serum Albumin/interferon alpha2a Fusion Protein 300-1200 mcg at Day 0 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events after single dose | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentration of interferon after single dose | 4 weeks | |
| Plasma concentration of Neopterin after single dose | 4 weks |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Ning Li, MD | 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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| Peginterferon 180 mcg single dose S.C. | Biological | Pegasys 180 mcg S.C. single dose on Day 0 |
|
| ID | Term |
|---|---|
| D000075462 | Serum Albumin, Human |
| D000077190 | Interferon alpha-2 |
| ID | Term |
|---|---|
| D012709 | Serum Albumin |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001798 | Blood Proteins |
| D016898 | Interferon-alpha |
| D007370 | Interferon Type I |
| D007372 | Interferons |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D001685 | Biological Factors |
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