Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:18 PM
Ignite Modification Date:
2025-12-24 @ 7:18 PM
NCT ID:
NCT01319903
Eligibility 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
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT01319903
Study Brief:
Protocol Section:
NCT01319903