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 @ 2:42 AM
Ignite Modification Date:
2025-12-25 @ 2:42 AM
NCT ID:
NCT02343133
Eligibility Criteria:
Inclusion Criteria:
Male and Female healthy subjects who have signed the informed consent form must meet all of the following criteria
* ≥18 to ≤75 years of age
* Body mass index (BMI) ≥ 18 and ≤ 35 kg/m2
* Normal ECG, vital signs and laboratory test results
* Use of effective birth control method and abstinence from sex
* Negative pregnancy test and drug screen
Exclusion Criteria:
Subjects with any of the following characteristics will be considered ineligible:
* History of clinically significant renal, hepatic pulmonary, cardiovascular, cerebrovascular, gastrointestinal, metabolic, hematological, endocrine, urological, immunological, neurologic or psychiatric disorders or connective tissue disease
* Positive for human immunodeficiency virus (HIV), Hepatitis B, or surface antigen (HBsAg) or Hepatitis C antibody, tuberculosis (TB)
* Drug or alcohol addiction
* History of clinically significant allergy of any kind
* Prior use of IL-12 or HemaMax
* Use of any approved or investigational biologic agents or vaccinations of any kind in last 3 months
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02343133
Study Brief:
Protocol Section:
NCT02343133