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:
2025-12-25 @ 12:17 AM
Ignite Modification Date:
2025-12-25 @ 12:17 AM
NCT ID:
NCT04848558
Eligibility Criteria:
Inclusion Criteria:
* Healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening
* Healthy on the basis of clinical laboratory tests performed at screening
* Continuous non-smoker
* A woman of childbearing potential must have a negative pregnancy test
* It is recommended that participants are up to date on all age appropriate vaccinations prior to screening as per routine local medical guidelines
Exclusion Criteria:
* Has a history of liver or renal insufficiency; cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
* Currently has a malignancy or has a history of malignancy within 3 years before screening
* Known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients
* Has received a live vaccine within 3 months prior to screening or has a known need to receive a live vaccine during the study, or within at least 3 months after the last administration of study intervention in this study
* Shows evidence of an active or chronic hepatitis B infection
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT04848558
Study Brief:
Protocol Section:
NCT04848558