Rheumatoid arthritis
Conditions
Sponsors
Yonemura Takuma
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Japanese healthy male subjects aged 20 to 44 years, with body mass index (BMI) of >= 18.5 and < 25.0 kg/m2.
Exclusion criteria
Exclusion criteria: 1. History or presence of illness (including drug or alcohol dependence, drug allergy, allergic disease (including severe natural rubber-latex allergy), respiratory disease, endocrine, renal, or hepatic disease, diabetes mellitus, or cardiac disease) 2. A history of cancer. 3. History or presence of psychiatric disease. 4. Evidence of any significant bacterial, viral, fungal, or parasitic infection within 28 days before dosing. 5. Positive for any one of infectious disease testing (Hepatitis B surface (HBs), anti-HBc antibody, Hepatitis C virus (HCV), Human immunodeficiency virus (HIV) antigen-antibody), and tuberculosis. 6. Positive for any one of drugs of abuse test. 7. History of hepatitis B. 8. Participated in another clinical study or any other type of medical research within 4 months before dosing. 9. Previous treatment with adalimumab. 10. Receipt of a live vaccine (e.g., BCG, polio, measles, rubella) within the 3 months before dosing. 11. History of ADAs to any drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics parameters for bioequivalence: Cmax, AUC0-360, AUC0-t | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary pharmacokinetics parameters: AUC0-infinity, Tmax, T1/2 Safety evaluation: Adverse event, Laboratory tests, 12-lead electrocardiogram (ECG), anti-drug antibody (ADA), Local tolerability (injection site reaction, Visual Analogue Scale (VAS) for pain at the injection site) | — |
Contacts
Public ContactYasumasa Arai
Fujifilm Kyowakirin Biologics Co. Ltd.
Outcome results
None listed