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 @ 2:49 AM
Ignite Modification Date:
2025-12-25 @ 2:49 AM
NCT ID:
NCT02107833
Eligibility Criteria:
Inclusion Criteria:
* Healthy male age 18-45
* Body mass index (BMI) 18-30 kg/m2
* Male subjects or their partners must use an adequate method of contraception at all times during the study.
* Negative laboratory tests for HIV, HBcAb and HCV at the screening visit
* Naïve to any previous recombinant protein therapy
* Provide written informed consent
* Have the ability to understand the requirements of the study and to comply with the study protocol and dosing regimen
Exclusion Criteria:
* Clinical evidence of any active significant disease that could potentially compromise the ability of the Investigator to evaluate or interpret the effects of the study treatment on safety assessment, thus increasing the risk to the subject to unacceptable levels
* Presence of any acute or chronic diseases
* History of any allergies or protein-drug hypersensitivity
* Exposure to long-term steroid treatment within the last 12 months prior to the study
* Subject had a major operation in last 6 months
* Subject has received immunosuppressive treatment prior to the study
* Chronic use of any medication including vitamins
* Participation in another clinical trial during the previous 3 months (subject report)
* Reported history of alcohol or drug abuse
* Subjects with short bowel (more than 1 m removed of small bowel).
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT02107833
Study Brief:
Protocol Section:
NCT02107833