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Also known as PEG-IFN alfa-2a BA-free formulation (Test)
PEG-IFN alfa-2a BA-free formulation · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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 |
|---|---|---|
| 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). |
| 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). |
Inclusion Criteria: * Healthy female and male Chinese participants * Body mass index between 19 and 28 kilograms per square meter (kg/m\^2), inclusive * Participants determined as healthy by their medical history, physical examination, vital signs, electrocardiogram (ECG), and clinical laboratory m...
PEG-IFN alfa-2a BA-free formulation is an investigational pegylated interferon alfa-2a product that does not contain benzyl alcohol. It was studied in healthy volunteers in a bioequivalence trial comparing it with PEG-IFN alfa-2a (Pegasys) after subcutaneous administration. It is developed by Roche Holding AG.
PEG-IFN alfa-2a BA-free formulation is developed by Roche Holding AG, which trades under the ticker RHHBY. Roche is the sponsor of the bioequivalence study conducted for this formulation.
PEG-IFN alfa-2a BA-free formulation is in Phase 1 development. One Phase 1 trial has been completed, and no trials are currently active. The completed study was a bioequivalence study in healthy volunteers, so the formulation remains investigational and is not an approved product.
PEG-IFN alfa-2a BA-free formulation has been studied in one completed clinical trial, NCT02573025. That Phase 1 bioequivalence study compared the benzyl alcohol-free formulation with PEG-IFN alfa-2a (Pegasys) after subcutaneous administration in 277 healthy volunteers across Australia, Hong Kong, New Zealand, Singapore, and Taiwan.
PEG-IFN alfa-2a BA-free formulation is also known as PEG-IFN alfa-2a BA-free formulation (Test). It is a distinct benzyl alcohol-free version of pegylated interferon alfa-2a, and it was compared against PEG-IFN alfa-2a (Pegasys) in a bioequivalence study rather than being identical to Pegasys.
The Phase 1 trial NCT02573025 was a controlled, randomized bioequivalence study of PEG-IFN alfa-2a BA-free formulation versus PEG-IFN alfa-2a (Pegasys) following subcutaneous administration. It enrolled 277 healthy volunteers aged 18 years and older of all sexes, and the study has been completed.