Loading clinical trials...

Bioequivalence Phase I Study of BFI-751 Compared With EU and US-STELARA® in Healthy Adults | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

NCT04843631•BioFactura Australia Pty Ltd.

View on ClinicalTrials.gov

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 ® ).

Eligibility

Age

18 - 50 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Healthy volunteers will be included in the study if they meet all of the following criteria at screening, and after check-in on Day -1, prior to dose administration:
•1. Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects.
•2. Adult male and female volunteers, 18 to 50 years of age (inclusive).
•3. Subjects who smoke no more than 2 cigarettes or equivalent per week can be included in the study but must be willing to abstain from smoking 7 days prior to admission and during the confinement period. Subjects must have a negative test for cotinine prior to check-in on Day -1.
•4. Body mass index (calculated) within the range of 18 to 32 kg/m2 inclusive.
•5. Body weight ≥ 50 kg and ≤ 100 kg inclusive.
•6. Medically healthy without clinically significant abnormalities, including:
•1. Physical examination without any clinically significant findings, in the opinion of the Investigator.
•2. Systolic blood pressure (BP) in the range of 90 to 145 mm Hg (inclusive) and diastolic BP in the range of 50 to 90 mm Hg (inclusive) after at least 5 minutes in the supine position.
•3. Heart rate (HR) in the range of 40 to 100 beats/min (inclusive) after at least 5 minutes rest in a supine position.
+10 more criteria

Exclusion Criteria

•Healthy volunteers will be excluded from the study if there is evidence of any of the following at screening or after check-in on Day -1, prior to dose administration:
•1. 1\. Prior exposure to STELARA® (Ustekinumab).
•2. Have a history of hypersensitivity or allergic reactions (either spontaneous or following drug administration) to any of the active or formulation ingredients of the study treatments components.
•3. Have a history of or presence of disease determined by the PI to be clinically significant including:
•1. gastrointestinal (including diverticulitis, stomach ulcers, inflammatory intestinal disease, gastrointestinal perforations/fistulae/intra-abdominal abscess).
•2. any other internal, non-gastrointestinal fistulae that is at an increased risk of bleeding.
•3. haematological (including pancytopenia, aplastic anaemia or blood dyscrasia).
•4. renal, hepatic, pulmonary, neurologic, psychiatric, metabolic (including known diabetes mellitus), or
•5. allergic disease excluding mild asymptomatic seasonal allergies.
•4. Have a history of prolonged immunosuppressant therapy, or photochemotherapy treatment.
+32 more criteria

Locations (3)

Nucleus Network

Brisbane, Queensland, Australia

CMAX

Adelaide, South Australia, Australia

NZCR

Grafton, Auckland, New Zealand

Key Dates

Start Date

April 1, 2021

Primary Completion Date

December 8, 2021

Completion Date

December 8, 2021

Last Updated

March 25, 2022

Enrollment

216

ACTUAL participants

Conditions

Psoriasis

Interventions

BFI-751

DRUG

EU-STELARA®

DRUG

US-STELARA®

DRUG

A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis

NCT07449234

Psoriasis

View study

RECRUITINGPHASE3

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

NCT07116967

Plaque Psoriasis

View study

RECRUITINGPHASE3

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

NCT07250802

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 25, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis

Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis

Real-Life Evaluation of Guselkumab Dosing Interval Adjustments