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 @ 12:56 PM
Ignite Modification Date:
2025-12-24 @ 12:56 PM
NCT ID:
NCT01544361
Eligibility Criteria:
Inclusion Criteria:
* Aged 18 years up to and including 49 years at the time of first dose of investigational product
* Healthy by medical history, physical examination, and laboratory studies
* Body weight 50-125 kilogram (kg); body mass index 19.0-32.0 kilogram per square meter (kg/m\^2) (inclusive)
* Females must be of non-childbearing potential.
Exclusion criteria:
* Any acute illness within 30 days of screening
* Concurrent enrollment in another clinical trial
* The subject has a positive drug/alcohol screen at screening or Day -1
* Pregnancy
* Current cigarette smokers
* History of cancer other than non-melanoma skin cancer or in situ carcinoma of the cervix treated with apparent success
* Use of immunosuppressive medications
* Subjects who have an unresolved infection with any Neisseria species
* Subjects who have had their spleen removed for any reason.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
49 Years
Study:
NCT01544361
Study Brief:
Protocol Section:
NCT01544361