BioFactura Initiates P-I Study of BFI-751 (biosimilar, ustekinumab) in Australia and New Zealand

 BioFactura Initiates P-I Study of BFI-751 (biosimilar, ustekinumab) in Australia and New Zealand

BioFactura Initiates P-I Study of BFI-751 (biosimilar, ustekinumab) in Australia and New Zealand

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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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