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:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2025-12-26 @ 11:11 AM
NCT ID:
NCT07133828
Eligibility Criteria:
Key Inclusion Criteria:
* Have a body mass index between 18 and 32 kilograms per square meter (kg/m\^2), inclusive, at screening.
* Weight ≥ 50 kilograms (kg) at screening.
* Negative polymerase chain reaction (PCR) test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at Check-in prior to randomization.
* Must be in good health as determined by the Investigator.
Key Exclusion Criteria:
* History of any clinically significant cardiac, endocrine, gastrointestinal, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, or renal disease, or other major disease, as determined by the Investigator.
* History of severe allergic or anaphylactic reactions
* History of or ongoing malignant disease (with limited exceptions)
* Systolic blood pressure \>150 millimeters of mercury (mmHg) or \<90 mmHg.
* Clinically significant (as determined by the Investigator) electrocardiogram (ECG) abnormalities.
* History of or positive test for human immunodeficiency virus (HIV).
* Chronic, recurrent, or serious infection within 90 days prior to Screening.
* Symptoms of bacterial, fungal, or viral infection within 14 days prior to Screening.
* Any live or attenuated immunization within 14 days prior to Screening.
* Use of prescription medications, over-the-counter medications that alter hepatic or renal clearance, or nutraceuticals within 28 days prior to Check-in.
* MAD Cohorts only: Suicidal ideation with some intent to act within 6 months prior to the start of Screening or history of suicidal behavior within one year prior to Screening.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT07133828
Study Brief:
Protocol Section:
NCT07133828