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 @ 10:29 PM
Ignite Modification Date:
2025-12-24 @ 10:29 PM
NCT ID:
NCT06315335
Eligibility Criteria:
Inclusion criteria:
For all subjects:
* Male or female between 18 to 55 years old, overtly healthy
* Female participants must not be pregnant or breastfeeding
* Female participants must be either of non-childbearing potential or using a highly efficient birth control method
* Male participants must use acceptable contraception and refrain from sperm donation during the study 90 days
* Body mass Index within the range 18 to 30 kg/m\^2 (inclusive)
For Japanese subjects only:
Japanese descent as evidenced in appearance and verbal confirmation of familial heritage and is of Japanese descent with all 4 grandparents
For Caucasian subjects only:
Caucasian descent as evidenced in appearance and verbal confirmation of familial heritage and is of Caucasian descent with all 4 grandparents
Exclusion criteria:
* Participant has a known hypersensitivity to any components of the investigational medicinal product (IMP) or other biologic drugs or humanized antibodies (mAbs)
* Participant has clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe posttreatment hypersensitivity reactions
* Participant has abnormal blood pressure (BP) (outside the normal range)
* Participant has alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) \>1.5x upper limit of normal (ULN)
* Participant has a recent history or currently active clinically-significant bacterial, fungal, endoparasite, or viral (including hospitalization for coronavirus disease 2019 (COVID-19)) infection (within 6 months of the Screening Visit)
* Participant has a history of inflammatory bowel disease (includes Crohn's disease and ulcerative colitis)
* Participant has a history of diabetes
* Study participant has a corrected QT interval (QTc) \>450msec for male study participants or \>470msec for female study participants
* Participant has sensitivity to heparin or heparin-induced thrombocytopenia
* Participant has a positive test for substance of abuse, or is a regular alcohol consumer defined as an average weekly intake of \>14 units
* Participant has received any prescription or nonprescription medicines within 14 days (or 5 half-lives of the respective drug, whichever is longer) prior to the Baseline Visit, other than contraceptives or occasional use of analgesic
* Participant has received Bacillus Calmette-Guerin vaccinations within 1 year prior to the Baseline Visit or within 90 days after the final dose of investigational medicinal product (IMP)
* Participant has been treated with biologic agents (such as mAbs, including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to the Baseline Visit
* Participant has participated in another study of an IMP within the previous 90 days or 5 half-lives of the IMP (whichever longer), or is currently participating in another study of an IMP
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT06315335
Study Brief:
Protocol Section:
NCT06315335