Randomized, single-dose, parallel-arm, open-label Phase I trial to compare the pharmacokinetics, safety and tolerability of BI 695501 administered subcutaneously via prefilled syringe or autoinjector
Completed
- Conditions
- Rheumatoid arthritis10003816
- Registration Number
- NL-OMON42895
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 80
Inclusion Criteria
Healthy male or female subjects
Aged between 18 and 65 years (inclusive)
BMI of >17.5 to <35.0 kg/m2
Exclusion Criteria
Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. Blood donation of more than 500 mL within 30 days prior to administration of trial medication or intended donation during the trial. Chronic or relevant acute infections. Previous exposure to adalimumab or proposed adalimumab biosimilar drugs. Subjects with any immunological disorders or auto-immune disorders, (e.g., RA, lupus erythematosus, scleroderma, etc.).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>1. AUC0-1368 (area under the concentration-time curve of the analyte in plasma<br /><br>over the time interval from 0 to 1368 hours after dose).<br /><br>2. Cmax (maximum measured concentration of the analyte in plasma).<br /><br>3. AUC0-* (area under the concentration-time curve of the analyte in plasma<br /><br>over the time interval from 0 extrapolated to infinity).</p><br>
- Secondary Outcome Measures
Name Time Method <p>Pharmacokinetics: Tmax, lambdaz, t1/2, CL/F, VZ/F.</p><br>