Autoimmune disease
Conditions
Interventions
A single dose of 40 mg ONS-3010, EU-licensed Humira® or US-licensed Humira®
will be administered.
Sponsors
Oncobiologics Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Healthy male or female volunteers, 18-55 years of age, willing and able to provide written informed consent.
Exclusion criteria
Exclusion criteria: Diagnosis of tuberculosis or risk factors for (latent) tuberculosis; recent or planned vaccinations; recent infections, chronic infections, history of severe infections, or impaired immunity; dysplasia or malignancy; auto-immune disorder, demyelinating disease, or any other condition which, in the opinion of the investigator, would put the subject at risk.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoints are the following pharmacokinetic (PK) parameters: -AUC0-* and ratio of the geometric least square means of test to reference products and reference to reference product(s) and their associated 90% confidence intervals; -Cmax and ratio of geometric least square means of test to reference products and reference to reference product(s) and their associated 90% confidence intervals. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary PK endpoints include: -AUC0-t and ratio of geometric least square means of test to reference products and reference to reference product(s) and their associated 90% confidence intervals (secondary endpoint for EMA); -Other pharmacokinetic parameters including Tmax, kel, t1/2, clearance (CL/F), and Vd/F. Safety endpoints include: -AEs -Clinical laboratory and vital signs -Immunogenicity | — |
Countries
Netherlands
Outcome results
None listed