Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years - 50 Years|
- - 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.
- - 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.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|BioFactura Australia Pty Ltd.|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Jeffrey N Hausfeld, MDKristi McLendonEmir RedzepagicChristian Schwabe|
|Principal Investigator Affiliation||BioFactura Australia Pty Ltd.Nucleus NetworkCMAXNZCR|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Countries||Australia, New Zealand|
The disease, disorder, syndrome, illness, or injury that is being studied.
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 ® ).
Experimental: Arm A: BFI-751
On Day 1, participants will be randomised to receive a single SC dose of 45 mg/0.5mL BFI-751
Active Comparator: Arm B: EU-STELARA®
On Day 1, participants will be randomised to receive a single SC dose of 45 mg/0.5mL EU- STELARA®
Active Comparator: Arm C: US-STELARA®.
On Day 1, participants will be randomised to receive a single SC dose of 45 mg/0.5mL US- STELARA®
Drug: - BFI-751
Single use vial, solution
Drug: - EU-STELARA®
Pre-filled syringe, solution
Drug: - US-STELARA®
Pre-filled syringe, solution
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.