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 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
NCT ID:
NCT02873767
Eligibility Criteria:
Inclusion Criteria:
* Good physical and mental health
* At least 18 and less than 65 years of age
* Female subjects of childbearing potential must agree to use a highly effective method of birth control, during the study and for a period of 3 months after their last dose of study drug
Exclusion Criteria:
* Total Immunoglobulin G \<7 g/L or \>16 g/L at the Screening Visit
* Absolute neutrophil count \<1.5x10\^9/L and/or lymphocyte count \<1.0x10\^9/L
* Known viral hepatitis, has a positive test for Hepatitis B surface antigen or is Hepatitis C virus antibody positive
* Positive test to Human Immunodeficiency Virus (HIV) 1/2 antibodies
* Past medical history or family history of primary immunodeficiency
* Evidence of latent/active Tuberculosis (TB)
* Active infection or a serious infection within 6 weeks before the first dose of IMP
* Renal impairment
* Hepatic impairment
* Vaccination within 6 weeks before the Screening Visit or intent to have a vaccination before Day 43 of the Safety Follow-up Period
* Subject is splenectomized
* received any IMP or experimental procedure within 90 days before the first dose of IMP
* received UCB7665 in a clinical study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT02873767
Study Brief:
Protocol Section:
NCT02873767