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 @ 5:00 PM
Ignite Modification Date:
2025-12-24 @ 5:00 PM
NCT ID:
NCT04882150
Eligibility Criteria:
Inclusion Criteria:
* Women not of childbearing potential and men, ages 18 or local age of majority to 55 years, inclusive
* Healthy male and female non-Japanese participants without clinically significant deviation from normal in medical history, physical examination, electrocardiogram (ECG), and clinical laboratory determinations
* Body mass index (BMI) of 18 to 32 kg/m2, inclusive, and total body weight ≥ 50 kg
Exclusion Criteria:
* Known or suspected autoimmune disorder, including but not limited to rheumatoid arthritis, fibromyalgia, systemic lupus erythematosus, polymyalgia rheumatica, giant cell arteritis, Behcet's disease, dermatomyositis, MS, moderate to severe asthma, any autoimmune vasculitis, autoimmune hepatitis, or any other active autoimmune disease for which a participant requires medical follow-up or medical treatment
* Any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status
* Presence of any factors that would predispose the participant to develop infection
* A history of bacterial or fungal meningitis within 1 year prior to screening
* A history of intracranial or intraspinal bleeding
* Known intracranial space-occupying mass, including meningioma
Other protocol-defined inclusion/exclusion criteria apply
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT04882150
Study Brief:
Protocol Section:
NCT04882150