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 @ 5:41 PM
Ignite Modification Date:
2025-12-24 @ 5:41 PM
NCT ID:
NCT02114268
Eligibility Criteria:
Key Inclusion Criteria:
* Age 18 through 49 years and in good health by history, physical exam, and labs
* Weight greater than or equal to (\>=) 45 kilogram (kg) and less than or equal to (\<=) 110 kg at Screening
* Written informed consent prior to performing any protocol related procedures, including Screening evaluations
* Ability to complete the Follow-up period of 360 days
Key Exclusion Criteria:
* Acute illness including fever \>= 99.5 Fahrenheit (°F) on day of dosing
* Any drug therapy within 7 days prior to Day 1 (except contraceptives)
* Receipt of any investigational drug therapy within 120 days prior to investigational product dosing through 360 days after investigational product dosing
* Previous receipt of a monoclonal antibody (mAb)
* Pregnant or nursing mother
* Concurrent enrollment in another interventional study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
49 Years
Study:
NCT02114268
Study Brief:
Protocol Section:
NCT02114268