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Bioequivalence Randomised, Double-blind, 3-parallel -Group Phase I Study of BFI-751 Compared With EU-STELARA® and US-STELARA® in Healthy Adult Volunteers
BFI-751 is being developed by BioFactura Australia Pty Ltd as a biosimilar drug to Stelara® (EU licenced and US licenced) (ustekinumab) is a prescription biologic medicine used to treat people with Crohn's disease, Ulcerative Colitis, plaque psoriasis and psoriatic arthritis. Stelara® is an immune suppressant that reduces the effects of inflammatory proteins within the body.
This is the first time BFI-751 will be given to humans. The primary purpose of this study is to compare the pharmacokinetics (the study of what the body does to the drug, referring to the movement of any drug going into, through, and out of the body) by checking to see if the blood levels of 751-BFI are comparable with US-Stelara® and EU-Stelara® following a single injection under the skin.
The secondary purposes of this study are:
to assess the safety of BFI-751,
study how well the healthy volunteers tolerate it and
to also assess the immune response to it in healthy volunteers.
100 项与 BioFactura Australia Pty Ltd 相关的临床结果
0 项与 BioFactura Australia Pty Ltd 相关的专利(医药)
100 项与 BioFactura Australia Pty Ltd 相关的药物交易
100 项与 BioFactura Australia Pty Ltd 相关的转化医学