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 @ 2:02 AM
Ignite Modification Date:
2025-12-25 @ 2:02 AM
NCT ID:
NCT02284360
Eligibility Criteria:
Inclusion Criteria:
* Healthy male subjects with 18-50 years of age at the day of inclusion
* Written informed consent will be obtained prior to screening examination
* BMI of 19-27 (extremes included)
* Subjects are in good clinical and mental health as established by medical history, physical examination, vital signs, electrocardiogram, results of biochemistry, hematology, virology and urine analysis at the Screening Visit
Exclusion Criteria:
* Lack of willingness or capacity to co-operate appropriately
* Regular use of medications
* History of malignancies
* History of wound healing abnormalities
* Chronic dermatological disease
* History of chronic autoimmune diseases such as rheumatoid arthritis, inflammatory bowel disease, diabetes mellitus, Lupus erythematodus
* Tattoos in the region of planned punch biopsy
* Positive HIV serology or evidence of active hepatitis
* Allergy requiring medical treatment within 4 weeks before study initiation
* Active infection of fever \> 38°C within 7 days prior randomisation
* Blood donation within 4 weeks before study initiation
* Clinically relevant abnormalities in the laboratory testing, vital signs, ECG or physical examination
* Participation in another clinical trial with an investigational day within 4 weeks before study participation
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT02284360
Study Brief:
Protocol Section:
NCT02284360