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 @ 4:54 PM
Ignite Modification Date:
2025-12-24 @ 4:54 PM
NCT ID:
NCT01026350
Eligibility Criteria:
Inclusion Criteria:
* Healthy male volunteers ages 18-60
* If participating in sexual activity that could lead to pregnancy, the study volunteer must agree that two reliable methods of contraception will be used simultaneously while receiving the protocol-specified medication and for 1 month after stopping the medication
* Men \> 18 years.
* Ability and willingness of subject to provide informed consent
* Screening tests' results within 15% of normal values
Exclusion Criteria:
* Female
* Continuous use of the following medications for more than 3 days within 30 days of study entry:
* Immunosuppressives
* Immune modulators
* Systemic glucocorticoids
* Anti-neoplastic agents
* Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
* Serious illness requiring systemic treatment and/or hospitalization within 30 days prior to entry.
* Subjects with a clinically significant infectious, immune mediated or malignant disease
* Subjects with anemia (Hb \<10.5 gm/dl)
* Subjects with thrombocytopenia (platelets \<100K/µl)
* Subjects with lymphopenia (absolute lymphocyte count \<0.7)
* Subjects who were previously vaccinated against flu.
* Subject who received any vaccination within the last 6 months
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01026350
Study Brief:
Protocol Section:
NCT01026350