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This is an open-label, randomized, multi-center, single dose, two-period, two-sequence crossover study to investigate the bioequivalence of PEG-IFN alfa-2a BA-free formulation versus the reference market formulation (PEG-IFN alfa-2a [Pegasys®]) following subcutaneous administration via prefilled syringe in healthy Chinese participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Followed by Reference | Experimental | Participants will receive PEG-IFN alfa-2a BA-free formulation (Test) in Period 1, followed by PEG-IFN alfa-2a market formulation (Reference) in Period 2 on Day 1 of each period with a washout period of 14 to 21 days. |
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| Reference Followed by Test | Experimental | Participants will receive PEG-IFN alfa-2a market formulation (Reference) in Period 1, followed by PEG-IFN alfa-2a BA-free formulation (Test) in Period 2 on Day 1 of each period with a washout period of 14 to 21 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEG-IFN alfa-2a BA-free formulation (Test) | Drug | Participants will receive single injection of 180 micrograms (mcg) of PEG-IFN alfa-2a BA-free formulation, subcutaneously via prefilled syringe in either period 1 and 2 (each period having 35 days). |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Concentration (Cmax) for PEG-IFN alfa-2a | Predose (-1 Hour), Hour 1, 3, 5, 8, 12, 24, 48, 72, 84, 96, 120, 144, 168, 192, 216, 240, 312, 384, 480, 552, 648, 816 post Dose | |
| Area Under the Concentration-Time Curve (AUC) for PEG-IFN alfa-2a From Time Zero to 816 hours (AUC0-816h) | Predose (-1 Hour), Hour 1, 3, 5, 8, 12, 24, 48, 72, 84, 96, 120, 144, 168, 192, 216, 240, 312, 384, 480, 552, 648, 816 post Dose |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-Time Curve for PEG-IFN alfa-2a From Time Zero Extrapolated to Infinity (AUC0-inf) | Predose (-1 Hour), Hour 1, 3, 5, 8, 12, 24, 48, 72, 84, 96, 120, 144, 168, 192, 216, 240, 312, 384, 480, 552, 648, 816 post Dose | |
| Time to Reach Cmax (tmax) for PEG-IFN alfa-2a |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CMAX A division of IDT Australia Limited | Adelaide | South Australia | 5000 | Australia | ||
| The University of Hong Kong; Pharmacy Clinical Trials |
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| PEG-IFN alfa-2a market formulation (Reference) | Drug | Participants will receive single injection of 180 mcg of PEG-IFN alfa-2a market formulation, subcutaneously via prefilled syringe in either period 1 and 2 (each period having 35 days). |
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| Predose (-1 Hour), Hour 1, 3, 5, 8, 12, 24, 48, 72, 84, 96, 120, 144, 168, 192, 216, 240, 312, 384, 480, 552, 648, 816 post Dose |
| Terminal Half-Life (t1/2) for PEG-IFN alfa-2a | Predose (-1 Hour), Hour 1, 3, 5, 8, 12, 24, 48, 72, 84, 96, 120, 144, 168, 192, 216, 240, 312, 384, 480, 552, 648, 816 post Dose |
| Percentage of Participants With Adverse Events | Baseline up to 35 days post last dose of PEG-IFN alfa-2a (maximum up to 17.5 weeks) |
| Hong Kong |
| Hong Kong |
| The Chinese University of Hong Kong; Emergency Medicine | Shatin | 00000 | Hong Kong |
| Christchurch Clinical Studies Trust | Christchurch | 8011 | New Zealand |
| Auckland Clinical Studies Limited | Grafton | 1010 | New Zealand |
| SingHealth Investigational Medicine Unit; Haematology | Singapore | 169608 | Singapore |
| Changi General Hospital- Parent; Department of Rheumatology | Singapore | 529889 | Singapore |
| China Medical University Hospital;Oncology and Hematology Office Critical Care Center, 14H | Taichung | 404 | Taiwan |
| Taipei Medical University Hospital; Clinical Research Center | Taipei | 110 | Taiwan |
| ID | Term |
|---|---|
| C100416 | peginterferon alfa-2a |
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