Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Male, Caucasian subjects aged between 18-40 years (inclusive)
Healthy subjects as determined by medical history, physical examination
Body weight between 70 - 100 kg and BMI between 19 and 29 kg/m2, extremes incl
ECG recording based on a 12-lead ECG which is normal (PR < 210 ms, QRS <110 ms, QTC 380 -430 ms) or contains only slight deviations
Normal vital signs (after 5 minutes resting), blood pressure values (systolic > or equal to 100 and < or equal to 140 mmHg, diastolic > or equal to 50 and < or equal to 90 mmHg), heart rate between 45 and 90 beats per minute (bpm), body temperature < 37.5°C
Subjects who are able and willing to give written informed consent
Normal white blood cell count, CRP and IL-6 at screening and Day -1
Subjects must be using two acceptable methods for contraception (e.g. spermicide and condom) during the study and refrain from fathering a child in the 3 months following dosing

Exclusion Criteria:

In the opinion of the investigator subjects with clinically significant history or presence of cardiovascular, respiratory, renal, hepatic, metabolic, endocrinological, gastrointestinal, hematological, neurological, dermatological, psychiatric diseases, cancer or other major diseases;
Infection or known inflammatory process;
Known autoimmune diseases or immunodeficiency or known family history of autoimmune diseases or immunodeficiency;
Clinical significant allergic disease;
Known serum hepatitis or who are carriers of the Hepatitis B surface antigen or Hepatitis C antibodies or with a positive result to the test for HIV 1/2 antibodies;
Subjects who have received an investigational drug and/or a vaccination within 3 months prior to start of the treatment in study and those who anticipate receipt of a vaccine within 2 months after the last dose of study drug;
Subjects, who have received prior treatment within 1 year with monoclonal antibodies or other biologic agents;
The use of any concomitant prescription or non-prescription medication within 14 days prior to the first administration of study medication until follow-up; or treatment with medication that may affect immune function (e.g. immunoglobulins, corticosteroids) within 6 months before dosing;
Donation of blood (>400 ml) or blood products within the last 3 months prior to admission to the clinical unit or plasmapheresis within 4 weeks prior to study start;
Definite or suspected personal history of adverse reactions or hypersensitivity to drugs especially to the ingredients of the trial compound or to compounds with a similar structure;
Use of more than 5 cups or glasses of coffee, tea and / or cola per day;
Presence or history of drug and/or alcohol abuse or an average daily intake of more than 20 g alcohol per day;
Positive test for alcohol or drugs at screening and/or on Day -1;
Smokers of > 5 cigarettes/day or equivalent;
Subjects who are unlikely to be compliant and attend scheduled clinic visits as required;
Participation in this study on a previous dose level