Healthy adult volunteers Not Applicable
Conditions
Interventions
Three formulations of adalimumab (M923, US Sourced Humira and EU Sourced Humira)
Sponsors
Baxter Innovations GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or females of non-childbearing potential aged 18 to 55 years, inclusive 2. Healthy as determined by pre study medical history, physical examination, vital signs and 12-lead ECG 3. Clinical laboratory test results that are not clinically significant and are acceptable to the investigator at screening and admission to the clinical unit (Day -1) 4. Body weight between 60.0 and 100.0 kg and a body mass index (BMI) between 18.5 and 29.9 kg/m2, inclusive 5. Male subjects must have been vasectomized with confirmation of sterility or be willing to comply with the contraception restrictions for this study 6. Female subjects must have a negative pregnancy test at screening and on admission to the clinical unit (Day -1), must not be lactating, and must be of non-childbearing potential 7. Has smoked =10 cigarettes or 3 cigars or 3 pipes/day for at least 3 months prior to screening and is willing to comply with smoking restrictions during confinement at the study center 8. Willing and able to comply with the requirements of the study 9. Willing and able to sign a written informed consent
Exclusion criteria
Exclusion criteria: 1. Clinically significant allergic or hypersensitivity conditions 2. Tuberculosis, invasive systemic fungal infections, other severe opportunistic infections, recent serious infection, recent or recurrent herpes zoster infection, chronic or recurrent infections 3. Recent or planned other investigational trial participation 4. Alcohol abuse or drug abuse 5. Recent use of any prescribed or non prescribed medication other than paracetamol, vitamins and for females, hormone replacement therapy 6. Congestive heart failure 7. Signs or symptoms of demyelinating disease 8. Cancer 9. Impaired liver function 10. Immunodeficiency or other clinically significant immunological disorders 11. Anti-citrullinated protein antibodies at screening 12. Anti-drug antibodies to adalimumab at screening 13. Clinically relevant history or presence of medical disorders as judged by the investigator 14. Recent or planned receipt during the study of a live vaccine 15. Medical dietary restrictions 16. Subjects who cannot communicate reliably
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Observed maximum concentration (Cmax) 2. Area under the serum concentration-time curve from time zero to 336 hours [AUC(0-336)] 3. Area under the serum concentration-time curve from time zero extrapolated to infinity [AUC(0-inf)] PK blood samples will be taken pre-dose and up to and including Day 71 post-dose. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The area under the serum concentration-time curve from time zero to 1344 hours [AUC(0-1344)] 2. Area under the serum concentration-time curve from time zero to time of the last quantifiable concentration [AUC(0-last)] 3. Time of maximum concentration (tmax) 4. Terminal rate constant (?z) 5. Terminal half- life (t1/2) 6. Apparent volume of distribution following extravascular dosing (Vz/F) 7. Apparent volume of distribution at distribution equilibrium (Vss/F) 8. Apparent systemic clearance after extravascular dosing (CL/F) 9. Area under the concentration-time curve extrapolated from time t to infinity as a percentage of total AUC (%AUCex) Vital signs will be performed pre-dose and post-dose - ECGs will be performed pre-dose and post-dose. Clinical laboratory tests: pre-dose and post-dose. Adverse events: Day-1 till last visit. Injection site evaluation Day-1 till last visit | — |
Countries
United Kingdom
Outcome results
None listed