Rheumatoid arthritis
Conditions
Interventions
The volunteer will receive one single subcutaneous injection in the thigh of 40
mg BI 695501 in a 0.8 milliliter (mL) solution. BI 695501 will be given either
by a pre-filled syringe or by an autoin
healthy volunteers
Sponsors
Boehringer Ingelheim
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Healthy male or female subjects Aged between 18 and 65 years (inclusive) BMI of >17.5 to
Exclusion criteria
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.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. AUC0-1368 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 1368 hours after dose). 2. Cmax (maximum measured concentration of the analyte in plasma). 3. AUC0-* (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity). | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics: Tmax, lambdaz, t1/2, CL/F, VZ/F. | — |
Countries
Belgium, Netherlands
Outcome results
None listed