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 @ 3:48 PM
Ignite Modification Date:
2025-12-24 @ 3:48 PM
NCT ID:
NCT04194892
Eligibility Criteria:
Inclusion Criteria:
* Must have a body mass index (BMI) between 19.0 and 32.0 kilograms per meter squared (kg/m²) at study screening
* Must be Human Immunodeficiency Virus (HIV) negative by HIV 1/0/2 testing.
* Must be Hepatitis B (HBV) surface antigen negative
* Must be Hepatitis C (HCV) antibody negative
* Females must have a negative serum pregnancy test
Exclusion Criteria:
* Pregnant or lactating subjects
* Have previously participated in an investigational trial involving administration of any investigational compound within 30 days prior to the study dosing
* Current alcohol or substance abuse judged by the Investigator to potentially interfere with subject compliance
* Have smoked or used tobacco/nicotine products within 90 days prior to the study dosing
* Have been treated with systemic steroids, immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening, or expected to receive these agents during the study (e.g., corticosteroids, immunoglobulins, and other immune- or cytokine-based therapies)
* Have been vaccinated within 90 days of study dosing
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT04194892
Study Brief:
Protocol Section:
NCT04194892