Shots:
- The company initiate a pivotal PK P-I clinical trial assessing the efficacy of BFI-751 vs Stelara in healthy human volunteers, with the authorization of Ethics Committees in both Australia and New Zealand
- The primary objective of the study is to compare PK of BFI-751 to US & EU-Stelara following a single dose under the skin. The study will also assess the safety & tolerability of BFI-751 in 210 healthy volunteers and their immune response
- The first three sentinel groups have been dosed with no AEs reported to date. The safety review committee has recommended the study progress with the opening of all three clinical sites which are now accepting new volunteers for the trial
Click here to read full press release/ article | Ref: BioBuzz | Image: Businesswire
The post BioFactura Initiates P-I Study of BFI-751 (biosimilar, ustekinumab) in Australia and New Zealand first appeared on PharmaShots.
