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:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-26 @ 3:14 PM
NCT ID:
NCT07456059
Eligibility Criteria:
Inclusion Criteria:
* Adult, male or female, 18-55 years of age, inclusive.
* Medically healthy based on a medical evaluation (including medical history, physical examination, vital signs measurement, 12-lead ECG, and clinical laboratory evaluations) performed at screening.
* Meets the protocol-specified criteria to qualify as a Japanese or Caucasian participant.
* BMI ≥ 18.0 and ≤ 35.0 kg/m2 at screening.
* Heart rate ≥ 45 and ≤ 99 bpm, systolic blood pressure ≥90 and \<140 mmHg, and diastolic blood pressure ≥ 50 to ≤ 90 mmHg at screening.
* eGFR ≥ 80 mL/min/1.73 m2 calculated using the CKD-EPI formula at screening.
* Female and male participants must follow protocol-specified contraception guidance.
Exclusion Criteria:
* History or evidence of any clinically significant cardiovascular, dermatologic, gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic, neurologic, psychiatric, pulmonary, renal, respiratory, and/or other major disorders or malignancy.
* History or evidence of any disorder that may interfere with the absorption, distribution, metabolism, or excretion of drugs.
* Positive test for hepatitis B surface antigen (HBsAg), hepatitis C antibody, or human immunodeficiency virus (HIV).
* History of significant blood loss, donation of blood, or received a transfusion of any blood or blood products within 60 days prior to screening.
* History of plasma donation within 7 days prior to screening.
* History of use of tobacco- or nicotine-containing products within six months prior to screening.
* Participating in another interventional clinical study or has used an investigational drug within 30 days or 5 half-lives prior to screening.
* History of alcohol and/or illicit drug abuse within 2 years of study participation.
* Positive urine test for alcohol or a positive urine drug test at screening or check-in.
* Breastfeeding or has a positive serum pregnancy test at screening or check-in.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT07456059
Study Brief:
Protocol Section:
NCT07456059