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 @ 2:46 AM
Ignite Modification Date:
2025-12-25 @ 2:46 AM
NCT ID:
NCT06640933
Eligibility Criteria:
Key Inclusion Criteria:
* Have a body mass index (BMI) of 18 to 32 kilograms per meter square (kg/m\^2), inclusive, and a total body weight \>50 kg, Screening and Day -1.
* Negative polymerase chain reaction (PCR) test result for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at Check-in (Day -1).
* For Japanese participants:
* Have biological parents and grandparents of Japanese origin.
* If living outside of Japan for more than 5 years, must not have significantly modified diet since leaving Japan.
Key Exclusion Criteria:
* History of any clinically significant cardiac, endocrine,gastrointestinal (GI), hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, or renal disease or other major disease, as determined by the Investigator.
* History of torsades de pointes or additional risk factors for torsades de pointes.
* Chronic, recurrent, or serious infection (e.g., pneumonia, septicemia), as determined by the Investigator, within 90 days prior to Screening or between Screening and Day -1.
NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT06640933
Study Brief:
Protocol Section:
NCT06640933