Bioequivalence Phase I Study of BFI-751 Compared With EU and US-STELARA® in Healthy Adults
Status:
Recruiting
Trial end date:
2022-01-01
Target enrollment:
Participant gender:
Summary
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.