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 @ 7:22 PM
Ignite Modification Date:
2025-12-24 @ 7:22 PM
NCT ID:
NCT01015703
Eligibility Criteria:
Inclusion Criteria:
* Adult males or females of non child-bearing potential aged 25 to 65 years inclusive and between 19 and 35 kg/m2 body mass index (BMI)
* Generally healthy as determined by pre study medical history, physical examination, 12 lead ECG.
* Negative for hepatitis B surface antigen (HBsAg), hepatitis C antibody and human immunodeficiency virus (HIV) I and II tests at screening and rapid influenza diagnostic test at admission.
Exclusion Criteria:
* History of alcohol abuse in the last 5 years or drug abuse at any time, current significant alcohol consumption.
* Fever, active infections (such as influenza) and acute gastrointestinal symptoms following prior to first dosing
* Subjects with a previous serious reaction to a vaccine, such as angioedema or anaphylaxis
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
65 Years
Study:
NCT01015703
Study Brief:
Protocol Section:
NCT01015703