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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 a pegylated interferon alfa-2a product being developed by Roche Holding AG (RHHBY) for use in healthy volunteers. It is currently in Phase 1 clinical development as an investigational drug, and it is not approved for any indication.
PEG-IFN alfa-2a BA-free formulation is developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical trials to evaluate this investigational product.
PEG-IFN alfa-2a BA-free formulation is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed.
PEG-IFN alfa-2a BA-free formulation has one completed clinical trial, NCT02573025, which was a bioequivalence study comparing it to Pegasys following subcutaneous administration. The trial enrolled 277 healthy volunteers and was conducted in Australia, Hong Kong, New Zealand, Singapore, and Taiwan.
PEG-IFN alfa-2a BA-free formulation is a benzyl alcohol (BA)-free version of pegylated interferon alfa-2a, which is being compared to Pegasys in clinical trials. It is an investigational formulation developed by Roche, while Pegasys is the existing branded product.