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:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-25 @ 2:28 AM
NCT ID:
NCT01681134
Eligibility Criteria:
Inclusion Criteria:
* Caucasian
* No previous/current history of infection, cerebrovascular, neurological, cardiovascular, endocrine, pulmonary, immunologic or metabolic disease or significant systemic disease, glucose intolerance, gout or hematological disorder
* Normal 12-lead Electrocardiogram (ECG)
* Systolic blood pressure \<140 mm Hg and diastolic blood pressure \<90 mm Hg
* Non-smoker within 3 months prior to screening
* Willing to abstain from alcohol during the study
Exclusion Criteria:
* Positive screen for illicit drug or alcohol consumption
* Subject has hepatitis B, hepatitis C, human immunodeficiency virus (HIV) or history of cancer (excluding completely excised squamous or basal cell carcinoma)
* Positive tuberculin skin test or known history of tuberculosis infection
* Known history of serious head injuries, seizures or eating disorders
* Body Mass Index \<18.0 or \>30.0
* History of renal dysfunction, clinically significant creatinine or clinically significant abnormal liver function tests, hemoglobin \<130 g/L
* Plasma donation ≥ 500 mL within 7 days prior to first dose of study drug, donation or whole blood loss 50-499 mL within 30 days or ≥ 499 mL within 56 days prior to first dose of study drug.
* Drug or alcohol abuse within 1 year prior to study entry
* Steroid injections within 12 weeks prior to first dose of study drug
* Live vaccine within 7 days prior to first dose of study drug
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT01681134
Study Brief:
Protocol Section:
NCT01681134