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 @ 10:50 PM
Ignite Modification Date:
2025-12-24 @ 10:50 PM
NCT ID:
NCT01493869
Eligibility Criteria:
Inclusion Criteria:
* Body weight must be ≥50 kg and \<130 kg with a BMI of ≥18 (kg/m2) and ≤36.0 (kg/m2).
* Must use acceptable forms of birth control during the course of the study and for 3 months following the single dose of study drug.
* Female subjects of childbearing potential must have a negative pregnancy test at screening and check-in.
* Must have adequate vital sign reads at screening and check-in.
* Must be able to comply with dietary and fluid restrictions required for the study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01493869
Study Brief:
Protocol Section:
NCT01493869