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 @ 4:56 AM
Ignite Modification Date:
2025-12-25 @ 4:56 AM
NCT ID:
NCT06168318
Eligibility Criteria:
Inclusion Criteria:
1. Participants must be 18 to 55years of age.
2. Participants who are overtly healthy.
3. Negative (Severe Acute Respiratory Syndrome Coronavirus 2) SARs-CoV-2 test prior to dosing.
4. Has body mass index (BMI) within the range 19-32 (kg/m2).
5. Participants male at birth must use male condoms, and participants female at birth who are of childbearing potential must be using acceptable forms of birth control.
6. Capable of giving signed informed consent.
Exclusion Criteria:
1. History or presence of disorders capable of significantly altering the absorption, metabolism, or elimination of drugs.
2. Abnormal blood pressure.
3. Any malignancy within the past 5 years except certain localized malignancies, or breast cancer within the past 10 years.
4. Has exclusionary psychiatric, hepatic, cardiovascular, gastrointestinal, respiratory, endocrine, neurological, hematological, or renal condition.
5. Current or chronic history of liver disease or known hepatic or biliary abnormalities.
6. Participants with exclusionary electrocardiogram findings.
7. Past or intended use of exclusionary medications or vaccines.
8. Exposure \> 4 new investigational products within 12 months, previous participation in this study, or current enrolment or participation in another investigational study.
9. ALT \>1.5x upper limit of normal (ULN), total bilirubin \>1.5x ULN, and/or estimated serum creatinine clearance \<60 mL/min.
10. History of or current infection with hepatitis B or hepatitis C.
11. Positive SARS-CoV-2 test, having signs and symptoms suggestive of COVID-19, or contact with known COVID-19 positive person.
12. Positive HIV antibody test.
13. Participants with positive results for illicit drug use, regular use of drugs of abuse, tobacco or nicotine-containing product use, and/or excessive alcohol use.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT06168318
Study Brief:
Protocol Section:
NCT06168318