NCT04843631

Bioequivalence Phase I Study of BFI-751 Compared With EU and US-STELARA® in Healthy Adults

Bioequivalence Randomised, Double-blind, 3-parallel -Group Phase I Study of BFI-751 Compared With EU-STELARA® and US-STELARA® in Healthy Adult Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 216 (actual)
• Sponsor: BioFactura Australia Pty Ltd. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a two centre, bioequivalence, randomized, double-blind, 3 parallel group Phase 1 study of BFI-751 compared with EU-Stelara ® and US-Stelara ® in healthy adult volunteers. Within 28 days of screening, eligible participants will commence a confinement period on Day -1. The participants will receive a 45mg dose of either BFI-751, Stelara-US ® or Stelara-EU® in a blinded manner on Day 1 and will remain in the clinic until Day 2. Participants will then return to the clinic as outpatients on Days 3, 5, 8, 11, 15, 22, 29, 36, 43,57, 71 and 85 for safety assessments. A total of up to 228 eligible participants will be enrolled and randomised in a 1:1:1 ratio (BFI-751: EU-Stelara ® : US-Stelara ® ).

Conditions

• Psoriasis

Interventions

Type	Name	Description
DRUG	BFI-751	Single use vial, solution
DRUG	EU-STELARA®	Pre-filled syringe, solution
DRUG	US-STELARA®	Pre-filled syringe, solution

Timeline

• Start date: 2021-04-01
• Primary completion: 2021-12-08
• Completion: 2021-12-08
• First posted: 2021-04-13
• Last updated: 2022-03-25

Locations

3 sites across 2 countries: Australia, New Zealand

Regulatory

• FDA-regulated drug study