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

NCT04843631 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 216

Last updated 2022-03-25

No results posted yet for this study

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.

Conditions

Interventions

DRUG

BFI-751

Single use vial, solution

DRUG

EU-STELARA®

Pre-filled syringe, solution

DRUG

US-STELARA®

Pre-filled syringe, solution

Sponsors & Collaborators

  • Avance Clinical Pty Ltd.

    collaborator INDUSTRY

  • BioFactura Australia Pty Ltd.

    lead INDUSTRY

Principal Investigators

  • Jeffrey N Hausfeld, MD · BioFactura Australia Pty Ltd.

  • Kristi McLendon · Nucleus Network

  • Emir Redzepagic · CMAX

  • Christian Schwabe · NZCR

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-01
Primary Completion
2021-12-08
Completion
2021-12-08
FDA Drug
Yes

Countries

  • Australia
  • New Zealand

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04843631 on ClinicalTrials.gov