A Randomized, Double Blind, Single Dose Study to Assess the Pharmacokinetics, Safety, and Tolerability of ONS-3010 (Adalimumab, Oncobiologics, Inc.) Compared to Two Reference Products of Humira® (Abbvie) in Healthy Adult Subjects
Completed
- Conditions
- Autoimmune disease10003816
- Registration Number
- NL-OMON41013
- Lead Sponsor
- Oncobiologics Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 180
Inclusion Criteria
Healthy male or female volunteers, 18-55 years of age, willing and able to provide written informed consent.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoints are the following pharmacokinetic (PK) parameters:<br /><br>-AUC0-* and ratio of the geometric least square means of test to reference<br /><br>products and reference to reference product(s) and their associated 90%<br /><br>confidence intervals;<br /><br>-Cmax and ratio of geometric least square means of test to reference products<br /><br>and reference to reference product(s) and their associated 90% confidence<br /><br>intervals.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary PK endpoints include:<br /><br>-AUC0-t and ratio of geometric least square means of test to reference products<br /><br>and reference to reference product(s) and their associated 90% confidence<br /><br>intervals (secondary endpoint for EMA);<br /><br>-Other pharmacokinetic parameters including Tmax, kel, t1/2, clearance (CL/F),<br /><br>and Vd/F.<br /><br><br /><br>Safety endpoints include:<br /><br>-AEs<br /><br>-Clinical laboratory and vital signs<br /><br>-Immunogenicity</p><br>